MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN TIB POR 2 PEG SZ G L; PROSTHESIS, KNEE

Catalog Number	42530007901
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown femoral component.Unknown articular surface.Customer has indicated that 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 that in an unknown timeframe post implantation of a left total knee arthroplasty, the patient underwent a revision and the tibial component was noted to have had one of the pegs fractured off.Attempts have been made and no additional information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6.The event is confirmed.Visual examination of the provided photo identified a tibial component in the patient with a peg fractured off.No product was returned therefore no further evaluations can be made.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.Medical records were not provided.A definitive 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: PSN TIB POR 2 PEG SZ G L
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22827076
• Report Number: 0001822565-2025-02979
• Device Sequence Number: 19971685
• Product Code: MBH
• UDI-Device Identifier: 00889024510593
• UDI-Public: (01)00889024510593(17)340923(10)66908288
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 42530007901
• Device Lot Number: 66908288
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male