MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL FEMORAL DIAPHYSEAL CONE, 30MM, MEDIUM, RIGHT; PROSTHESIS, KNEE

Catalog Number	00545001831
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00588001502, fem size e right, lot# 65577833.00599003523, ng 15mm dist only fem augm sze, lot# 64574554.00599003524, 20mm distal only fem aug sz e, lot# 63251030.00598802011, 11mm dia 100mm length offset stem ext 145mm, lot# 63988012.00588005012, 12mm height size e articular surface with hinge post, lot# 65532680.00801102024, allen medullary cement plugs 1- 24mm dia, flange/12 mm dia, lot# 65626531.G2: australia.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient was revised for femoral loosening two years, three months post implantation.Attempts have been made and no additional information has been provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2b, d9, g1, g3, g6, h1, h2, h3, h4, h6, and h11.Corrected: d6b, h6 (component code).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.

• Brand Name: TRABECULAR METAL FEMORAL DIAPHYSEAL CONE, 30MM, MEDIUM, RIGHT
• 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: 23424347
• Report Number: 3005751028-2025-00018
• Device Sequence Number: 8179470
• Product Code: MBH
• UDI-Device Identifier: 00889024308411
• UDI-Public: (01)00889024308411(17)250815(10)64800341
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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 Expiration Date: 08/15/2025
• Device Catalogue Number: 00545001831
• Device Lot Number: 64800341
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Male