MAUDE Adverse Event Report: ZIMMER TMT NEXGEN TRABECULAR METAL STANDARD PRIMARY PATELLA 35MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10 - concomitant devices - persona cruciate retaining standard porous femoral component catalog #: 42502807001 lot #: 65741969, persona medial congruent articular surface left 11mm catalog #: 42512100911 lot #: 65178181, persona trabecular metal two-peg porous tibial component left size g catalog #: 42530007901 lot #: 65462661 g2 - report source - foreign: event occurred in australia.Visual evaluation of pictures provided confirm the patella was fractured.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.This report was previously submitted erroneously on jul 10, 2025 and oct 14, 2025 under manufacturing report number 0001822565-2025-02458.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision due to patella implant fracture approximately two (2) years post-operatively.Attempts have been made, however, no additional information is available.

• Brand Name: NEXGEN TRABECULAR METAL STANDARD PRIMARY PATELLA 35MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23303703
• Report Number: 3005751028-2025-00017
• Device Sequence Number: 17359396
• Product Code: MBH
• UDI-Device Identifier: 00889024309814
• UDI-Public: (01)00889024309814(17)270413(10)65320386
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00587806535
• Device Lot Number: 65320386
• 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: 09/23/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male