MAUDE Adverse Event Report: ZIMMER TMT NEXGEN TRBECULAR METALL FULL CONE; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10: concomitant devices - nexgen offset stem extension 14mm x 100mm catalog #: 00598802014 lot #: 63632065, nexgen stemmed precoat tibial component size 3 catalog #: 00598003701 lot #: 63544274, nexgen straight stem extension 18mm x 100mm catalog #: 00598801018 lot #: 63282086, nexgen cemented option femoral component left size d catalog #: 00599401491 lot #: 63746608, nexgen distal femoral augment block catalog #: 00599003410 lot #: 62999435, nexgen distal femoral augment block catalog #: 00599003410 lot #: 62963054.G2: foreign - event occurred in new zealand h10: this device was erroneously reported under an incorrect mfr, and is now being submitted under the appropriate mfr.See original report 0001822565-2024-01362.The product was evaluated through manufacturing review; however, the reported event could not be confirmed.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.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision approximately six (6) years post-operatively to address femoral pain.Attempts have been made and no further information has been provided.

• Brand Name: NEXGEN TRBECULAR METALL FULL CONE
• 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: 24815785
• Report Number: 3005751028-2026-00022
• Device Sequence Number: 9594302
• Product Code: MBH
• UDI-Device Identifier: 00889024308503
• UDI-Public: (01)00889024308503(17)211130(10)63525256
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K053340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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): 04/08/2026

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 Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00545004801
• Device Lot Number: 63525256
• 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: 03/17/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2016
• 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 Sex: Female