MAUDE Adverse Event Report: Zimmer Biomet, Inc. Biomet 360 TIB TRAY 75MM; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented

Catalog Number	185204
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the locking bar didn't fit in the bearing and the tibial tray, so the surgery was completed with a new locking bar.The surgeon suspected that the locking bar and bearing might have been deformed prior to use as they could not smoothly insert the locking bar into the tibial plate.There was a less than 30 minute surgical delay.The surgical technique was utilized.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: ve183641 - vgd ve ps tib brg 71/75x11mm - 67436434.G2 : foreign country : japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: Biomet 360 TIB TRAY 75MM
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented
• Manufacturer (Section D): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50867958
• Report Number: 0001825034-2026-02832
• Device Sequence Number: 9379694
• Product Code: JWH
• UDI-Device Identifier: 00880304481435
• UDI-Public: (01)00880304481435(17)351017(10)67550188
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 185204
• Device Lot Number: 67550188
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• 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.
• Patient Sex: Unknown