MAUDE Adverse Event Report: ZIMMER GMBH METASUL DUROM, COMPONENT FOR FEMUR, CEMENTED, 50/P; DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.It is unknown if the patient has been revised.As no lot numbers were provided for the devices, the device history records could not be reviewed.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department.An e-mail requesting additional information was went on april 19, 2017.As soon as supplemental information becomes available an updated report will be submitted.Zimmer¿s reference number of this file is cmp-(b)(4).

Event Description

The patient is pursuing a product liability claim.It was reported that the patient was implanted a zimmer hip mom implant on unknown side on unknown date.It is unknown if the patient was revised or is being monitored due to unknown reasons.

Manufacturer Narrative

As the case at hand is a legal claim it is not suspected that the devices or additional information are being submitted for review.Zimmer gmbh (b)(4) legal department have already passed all information that was received from the lawyer, to our complaint handling department.By experience zimmer gmbh never gets more information except for the one that has been already covered in the final report.Patients¿ advocates only provide to zimmer gmbh as much information as they are willing to share to protect the rights of their clients.All information which has been provided for this particular case is already covered in the final report.Nevertheless, should additional information become available to us, a follow up report will be submitted.A technical investigation was not possible to be performed, as the device was not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows.As no lot numbers were provided for the devices, the device history records could not be reviewed.At zimmer gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Event summary: patient underwent primary surgery with unknown mom hip implants, and pursuing legal claim due to unknown reasons.Note: this case is one of 25 claims reported by a lawyer regarding zimmer hip mom implants.No further information was provided.No medical data such as x-rays, surgical notes or any other case-relevant documents received.No product was returned to zimmer biomet for in-depth analysis.Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant(s) were received; therefore the condition of the component is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause cannot be determined.However, all possible causes related to the issues reported are listed in the dfmea which is available for every zimmer implant and is continuously monitored and updated.Conclusion summary: in conclusion, due to fact that problems experienced by the patient are unknown, the product implanted is unknown and no other information is available, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause cannot be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional and corrected information are filled in the following fields: d11: medical products and therapy date.Detail of product: item number: 0100634058.Item name: zimmer mmc cup, uncemented, 58 mm/50 mm, code p.Lot#: 2528482.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: METASUL DUROM, COMPONENT FOR FEMUR, CEMENTED, 50/P
• Type of Device: DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 6536723
• MDR Text Key: 74180937
• Report Number: 0009613350-2017-00555
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: K070292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 01.00211.150
• Device Lot Number: 2534951
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/02/2017
• Supplement Dates Manufacturer Received: 06/28/2017; 12/18/2019
• Supplement Dates FDA Received: 07/26/2017; 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other