MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL-POLY PATELLA CEMENTED 29 MM DIAMETER; PROSTHESIS, KNEE

Catalog Number	42540200029
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42502006601 femur cemented (cr) narrow left size 9 lot# 66055831.42512100513 articular surface medial congruent (mc) left 13 mm lot # 65541183.42532006701 tibia cemented 5 degree stemmed left size d lot # 66360624.42557000114 stem extension tapered cemented 14mm dia 30mm l lot # 66060290.G2: event occurred in australia.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This complaint is not confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that there was a revision tkr due to patella instability and maltracking.Attempts for additional information have been made and none is available.

• Brand Name: ALL-POLY PATELLA CEMENTED 29 MM DIAMETER
• 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 BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23996337
• Report Number: 0002648920-2026-00004
• Device Sequence Number: 10522861
• Product Code: MBH
• UDI-Device Identifier: 00889024247680
• UDI-Public: (01)00889024247680(17)300226(10)67158199
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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: Lay User/Patient
• Device Catalogue Number: 42540200029
• Device Lot Number: 67158199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown