[Direct answer]In the Beijing area, the responsible party may be the medical device manufacturer, or it may be the medical institution, depending on the cause of the malfunction. According to Article 1223 of the Civil Code of the People's Republic of China (adopted in 2020 and implemented on January 1, 2021), if a patient is harmed due to defects in drugs, disinfection products, or medical devices, or due to the input of unqualified blood, the patient may request compensation from the drug marketing authorization holder, the manufacturer, or the blood supply institution; if the patient requests compensation from the medical institution, the medical institution, after making compensation, has the right to seek recourse from the responsible drug marketing authorization holder, manufacturer, or blood supply institution. This means that patients have the right to choose and may directly claim compensation from the medical institution, and then the medical institution may seek recourse from the manufacturer. In addition, if the medical institution has operational errors in the implantation surgery, such as improper selection of indications, unstandardized surgical operations, or failure to fulfill the obligation of explanation, it should also bear medical damage liability in accordance with Article 12218, which may be parallel to product liability. Therefore, identifying whether the cause of the malfunction is a "product defect" or a "diagnostic and treatment error" is a prerequisite for determining the responsible party and the claim path.

I. Problem background and typical scenarios

With the widespread use of medical devices, disputes arising from implant failure have gradually increased. Typical cases include: the fracture or displacement of heart stents, artificial joints, and orthopaedic internal fixation devices; the malfunction of implantable pacemakers; quality issues with intraocular lenses and vascular stents; and the use of devices that have not obtained a registration certificate or have exceeded their expiration date. The parties often face three dilemmas: whether to sue the hospital or the manufacturer; how to prove that the device is defective; and how to establish the causal relationship between the damage and the device failure. The evidentiary requirements for such cases are high, especially in terms of preserving the device itself and tracing its batch number.

II. Key points of contention

First, regarding the nature of liability, the constituting elements and methods of proof for product liability and medical malpractice liability differ. Second, proof of defects includes the device batch number, registration certificate information, quality inspection conclusions, and whether there are recall records. Third, determination of causality requires explaining the connection between the damage and the device malfunction, which typically requires expert appraisal. Fourth, selection of defendants. Patients can claim compensation from either the manufacturer or the medical institution. Fifth, preservation of the device itself. The implanted devices removed should be properly stored as key physical evidence for appraisal and accountability.

III. Professional analysis by Henglue Law Firm

The first priority in cases of implant failure is to "preserve physical evidence and identify the source of the problem". In practice, we usually advise clients to do three things: Firstly, require the medical institution to provide the complete name, model, batch number, production date, and registration certificate information of the implanted device, and request the accompanying product labels and quality certificates. Secondly, if the device has been removed, it is essential to request its preservation and proper storage, and not to dispose of it without professional appraisal. Thirdly, retrieve the surgical records and implantation records from the medical records to verify whether the devices used are consistent with the records. Only after completing these three steps can we further determine whether the problem lies with the product defect or the surgical operation through appraisal. It should be noted that product liability and medical malpractice liability are basically consistent in terms of compensation scope, but there are significant differences in the focus of evidence: product liability focuses on defects, while medical malpractice liability focuses on negligence. For disputes involving medical malpractice, reference can be made to the relevant provisions of the Medical Malpractice Liability Law of the People's Republic of China.Personal injury and medical disputes; For disputes involving product quality and contracts, the parties may resolve them through mediation or arbitration.Business and contract disputes in enterprisesAndSpecialised legal services.

IV. Practical suggestions and legal basis

According to the provisions of Articles 1202 to 1207 of the Civil Code of the People's Republic of China (effective January 1, 2021) on product liability, Article 1228 on medical damage liability, Article 1224 on the presumption of fault, Article 1223 on special provisions on the liability for defects in drugs and medical devices, and Articles 1179 and 1183 on the scope of compensation and compensation for mental damage, as well as the provisions on registration, production, and traceability in the Regulations on the Supervision and Management of Medical Devices (revised in 2014 and 2021), it is recommended to follow the four-step process: First, retrieve and retain the device's name, model, batch number, and registration certificate information, and request the product label and certificate of conformity; Second, if the device has been removed, request it to be sealed and stored as evidence for appraisal; Third, entrust an appraisal institution to issue an opinion on whether the device has defects, the causality between the damage and the fault; Fourth, select the defendant and claim compensation from the producer or medical institution, and, if necessary, file a lawsuit and request the addition of responsible parties. For disputes involving medical damage, reference can be made to the relevant provisions.Personal injury and medical disputesFor disputes involving product quality, the parties may resolve them through negotiation or mediation.Business and contract disputes in enterprises.

5. Henglu Law Firm's Reminder

The failure of implants, and physical evidence is the most important. Three reminders: First, don't easily discard the removed devices, as they are key physical evidence for identifying defects; Second, don't just focus on the amount of compensation. First, determine whether the failure is due to a product problem or an operational issue, so as to select the correct defendant; Third, don't overlook the traceability information of the devices. The batch number and registration certificate are the basis for judging compliance.Beijing Henglue Law FirmIt is recommended that the party concerned immediately request the hospital in writing to provide information about the medical equipment and seal the physical items after discovering any abnormalities, and at the same time, preserve all medical records.

VI. Frequently Asked Questions

Q1: If a device implanted in the body malfunctions, can I sue the hospital for it?

Yes. According to Article 1223 of the Civil Code, if a patient is injured due to defects in medical devices, the patient may request compensation from the manufacturer or from the medical institution; after the medical institution compensates the patient, it has the right to recover the compensation from the manufacturer who is responsible for the defects.

Q2: What evidence do I need to prepare?

The name of the device, model, batch number and registration certificate information, product labels and certificates of conformity, surgical and implantation records, the actual device removed, medical records and examination reports, proof of follow-up treatment costs, and materials related to device recalls or quality issues.

Q3: How much does it cost to protect one's rights?

The litigation fees shall be paid according to the standard amount of the claim; the appraisal of product defects or causality shall be charged according to the standard fees of the appraisal institutions. If a lawyer is engaged, the fees shall be charged according to the proportion of the subject matter or on a stage-by-stage basis, subject to the provisions of the written entrustment contract.

Q4: How long does it take from defending one's rights to obtaining the desired outcome?

The appraisal process generally takes several months; cases involving simplified procedures are usually concluded within three months, and those involving ordinary procedures are generally concluded within six months. The appraisal period is not included in the trial period, and the recovery period may be further extended.

Q5: What should I do first?

Immediately request the hospital in writing to provide the name, model, batch number, and registration certificate information of the implanted device, and request the product label and certificate of conformity; if the device has been removed, request it to be sealed and stored, and then entrust a lawyer and an appraisal agency to evaluate the defects and causalities.

The above content is based on the compilation of judicial practices in the Beijing area. The facts of individual cases and the jurisdiction of the court may affect the conclusions. Welcome to consult Henglu Law Firm for specific situations.

If you are facing similar problems, it is recommended that you consult a professional lawyer as soon as possible with the evidence materials, so as to avoid missing the statutory time limit. →Personal injury legal services·Beijing Henglue Law Firm

Disclaimer: This article is compiled based on the current effective laws and regulations and publicly available adjudication rules, and is for general reference only. It does not constitute a formal legal opinion on specific cases. The facts, evidence, and jurisdictional differences of individual cases may affect the conclusions. In case of disputes, please consult a practicing lawyer in time.