MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PATELLA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Peeled/Delaminated (1454); Naturally Worn (2988)

Patient Problem Joint Laxity (4526)

Event Date 11/30/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial knee procedure and approximately 16 years later, was revised due to instability and poly wear.Patella wear and delamination were seen from the provided images.The bearing and patella were exchanged by the surgeon.Attempts have been made and all available information has been provided.

Manufacturer Narrative

(b)(4).D10: 179274 - ascent con tib brg 18x71/75 - 204820.178054 - ascent clsd box ps fmrl lg l - 541710.141484 - biomet offset tibial tray 75mm - 778140.179075 - ascent rev fem stem 20x150 - 727740.141490 - offset tib tray 2.5mm adaptor - 393460.141616 - bmt splined knee stm 16x80 - 10880.3015-040 - cmw 1 gentamicin cement - 2064421.3015-040 - cmw 1 gentamicin cement -2064421.G2 : foreign country : australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-03013.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receiving additional information of the reported event, it was determined to be not reportable as no allegations were made against the device.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was further reported that the patella was revised due to standard practice.Attempts have been made and all available information has been provided.

• Brand Name: UNKNOWN PATELLA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18359958
• MDR Text Key: 330933242
• Report Number: 0001825034-2023-03014
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose