MAUDE Adverse Event Report: Zimmer TMT Trabecular Metal Diaphyseal Femoral Cone 30 Small Right; Prosthesis, Knee

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Periprosthetic fracture (4902)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address a femoral periprosthetic fracture after a fall approximately five (5) months post-operatively.No additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - orthopedic salvage system segmental elliptical femur right 7cm catalog #: 150356 lot #: 67131917, orthopedic salvage system cemented im stem 17mm x 90mm catalog #: 150364 lot lot#: 65790717, orthopedic salvage system modular tibial baseplate 67mm, catalog #: 150421, lot #: 66702470, orthopedic salvage system tibial sleeve augment small, catalog #: 161045, lot #: 67087297, orthopedic salvage system cemented im stem 12mm x 90mm, catalog #: 150361, lot #: 65752927, orthopedic salvage system reinforced yoke, catalog #: 150493, lot #: 67606806, orthopedic salvage system axle, catalog #: 150480, lot #: 67606790, orthopedic salvage system poly lock pin, catalog #: 150478, lot #: 67538553, orthopedic salvage system poly femoral bushings 2pk, catalog #: 150477, lot #: 66521551, orthopedic salvage system poly tibial bushing, catalog #: 150476, lot #: 67526913, orthopedic salvage system tibial poly bearing 16mm, catalog #: 150412, lot #: 67549312.G2 - report source - foreign: event occurred in australia.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: Trabecular Metal Diaphyseal Femoral Cone 30 Small 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 ; +1(574)526-0384
• MDR Report Key: 50410176
• Report Number: 3005751028-2026-00054
• Device Sequence Number: 10550989
• Product Code: MBH
• UDI-Device Identifier: 00889024308398
• UDI-Public: (01)00889024308398(17)290429(10)66481205
• 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: 2026
• Device Explanted Year: 2026
• 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): 08/24/2026

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 Model Number: N/A
• Device Catalogue Number: 00545001731
• Device Lot Number: 66481205
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• 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: Unknown