MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN MC VE ASF L 10MM 8-11/GH; PROSTHESIS, KNEE

Catalog Number	42512100910
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 2.5 years post implantation of a left knee arthroplasty, the patient underwent a revision due to instability.The tibial plate and articular surface were revised.Attempts for additional information were made and none is available.
Additional Manufacturer Narrative
(b)(4).D10: 42530007901, psn tib por 2 peg sz g l, lot 77012122; 42502806601, femur trabecular metal cruciate retaining (cr) standard porous, lot 65481209.G2: event occurred in australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h3, h6 the reported event was unable to be confirmed.Visual examination of the photos provided identified an explanted tibial component covered in bio-debris.No product was returned; therefore dimensional evaluations could not be made.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a healthcare professional.The findings were that the femoral component exhibits 2-3 degrees varus alignment with respect to the anatomic axis of the femur, rather than being in typical slight valgus alignment.The femoral component appears mildly small compared with the tibial component.Tibial component is medially positioned, resulting in mild medial overhang of the tibial tray and tibial tray not extending as far laterally on the lateral tibial plateau as expected.It is reported that the patient subsequently underwent revision due to instability.Possible risk factors for instability include slight varus positioning of the femoral component and relatively small femoral component compared with the tibial component.Operative or clinical notes 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information to report.

• Brand Name: PSN MC VE ASF L 10MM 8-11/GH
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• 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: 22779637
• Report Number: 3007963827-2025-00314
• Device Sequence Number: 13238280
• Product Code: MBH
• UDI-Device Identifier: 00889024469372
• UDI-Public: (01)00889024469372(17)270629(10)65410792
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 42512100910
• Device Lot Number: 65410792
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Male