MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PAT COMP 32DIA; PROSTHESIS, KNEE

Catalog Number	00597206532
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately nine years four months post implantation due to pain.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).D10- medical product: lps-flex option femoral e-r item# 00596401552 lot# 63246971.Option st tib plt size 3 item# 00598603701 lot# 63117093.Lps-flex fxd mld ef/3-4 09mm item# 00596403209 lot# 63094649.G2- united kingdom.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: ALL POLY PAT COMP 32DIA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24208918
• Report Number: 0002648920-2026-00014
• Device Sequence Number: 5431250
• Product Code: JWH
• UDI-Device Identifier: 00889024635388
• UDI-Public: (01)00889024635388(17)230930(10)63190434
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 00597206532
• Device Lot Number: 63190434
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female