MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER 8.5 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately four years and six weeks post implantation due to unknown reasons.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2024-00401, 3007963827-2024-00028, 0002648920-2024-00032.D10- medical product : articular surface size ef 12 mm height item# 00596403212 lot# 64066055.Femoral component option size e right item# 00596401552 lot# 64241488.Stemmed nonaugmentable tibial component option cr/ps/lps size 4 item# 00598603702 lot# 64210105.G2- united kingdom.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.The 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.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined that there are no allegations of malfunction against the patella.The initial report was submitted in error and should be voided.
Event or Problem Description
Upon receipt of additional information, it was determined that there are no allegations of malfunction against the patella.The initial report was submitted in error and should be voided.

• Brand Name: ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER 8.5 MM THICKNESS
• 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 MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18659105
• Report Number: 0002648920-2024-00031
• Device Sequence Number: 8213111
• Product Code: JWH
• UDI-Device Identifier: 00889024635388
• UDI-Public: (01)00889024635388(17)260831(10)64129894
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00597206532
• Device Lot Number: 64129894
• 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: 01/17/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female