MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN TIB POR 2 PEG SZ G L; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Catalog Number	42530007901
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: insert persona 10 mm, #item 42-5114-010-10, #lot 66679472.Fémur persona ps taille 10, #item 42-5008-068-01, #lot 64606010.Therapy date: (b)(6) 2026.G2: foreign: event occurred in france.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a knee revision approximately 9.5 months post-implantation due to a tibial component fracture.Following the onset of pain, evaluation revealed a fracture of the tibial implant.Attempts have been made and no further information has been provided.

• Brand Name: PSN TIB POR 2 PEG SZ G L
• Common Device Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
• 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: 24701292
• Report Number: 0001822565-2026-00968
• Device Sequence Number: 13306210
• Product Code: MBH
• UDI-Device Identifier: 00889024510593
• UDI-Public: (01)00889024510593(17)330916(10)66165387
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 09/22/2026

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 Catalogue Number: 42530007901
• Device Lot Number: 66165387
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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: Male