MAUDE Adverse Event Report: ZIMMER TMT NEXGEN POROUS PATELLA 35MM X 10MM; PROSTHESIS, KNEE

Catalog Number	00587806535
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee revision approximately two (2) years post-implantation after experiencing a fall that resulted in the post of the nexgen patella fracturing.During the revision, the patella was explanted; however, the fractured peg portion was unable to be removed and remains in the patient.No other patient consequences were reported as a result of the event.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).H10: this device was erroneously reported under an incorrect mfr, and is now being submitted under the appropriate mfr.See original report 0001822565-2024-03079.The event is confirmed.Visual inspection of the returned device found the device is fractured.Fracture surface analysis of the trabecular metal patella revealed no evidence of clear artifacts to deduce the mode of failure.The fracture appeared to be excessively smeared, possibly due to post fracture damage.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.X-rays were reviewed by a healthcare professional.Review of the x-rays confirms that the patella is fractured.It was reported that the patient fell however the reason for fall is unknown and hence a root cause cannot be determined.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.

• Brand Name: NEXGEN POROUS PATELLA 35MM X 10MM
• 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: 24650116
• Report Number: 3005751028-2026-00013
• Device Sequence Number: 10070012
• Product Code: JWH
• UDI-Device Identifier: 00889024309814
• UDI-Public: (01)00889024309814(17)270515(10)65389510
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K011904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00587806535
• Device Lot Number: 65389510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• 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: 03/19/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 91 KG