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

Catalog Number	42530007102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42522100710, articular surface medial congruent (mc) right 10 mm height use with tibia sizes e-f/cr femur sizes 6-7, lot 67161490.42502806002, femur trabecular metal cruciate retaining (cr) standard porous, lot 65561104 g2: event occurred in australia.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 approximately 1 month post implantation of a right total knee arthroplasty the patient underwent a revision for fracture of the tibial plateau that was caused by a fall.The cause of the fall is unknown.Attempts have been made and all additional information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided images reveals the explanted tibial plate and bearing.No damages can be seen on the explanted devices.No further assessment can be made.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fracture medial tibial plateau with distal displacement of medial tibial plateau fracture fragment, loosening of tibial component and varus tilt of the tibial component.Excessive valgus positioning of the femoral component could potentially cause excessive load on the medial tibial plateau increasing the risk of medial tibial plateau fracture.A definitive root cause cannot be determined 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.
Event or Problem Description
No additional information to report at this time.

• Brand Name: PSN TIB POR 2 PEG SZ E R
• 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: 22921514
• Report Number: 0001822565-2025-03188
• Device Sequence Number: 9162514
• Product Code: MBH
• UDI-Device Identifier: 00889024510562
• UDI-Public: (01)00889024510562(17)350217(10)66908249
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 11/20/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42530007102
• Device Lot Number: 66908249
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female