MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN FEM CR CMT CCR NRW SZ 7 L; PROSTHESIS, KNEE

Catalog Number	42-5020-062-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: psn mc ve asf l 10mm 6-7/ef, #item 42512100710, #lot 64832428.Psn tib stm 5 deg sz e l, #item 42532007101, #lot 64805374.Therapy date: on (b)(6) 2025.H6: component code.Mechanical (g04) - femur.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient underwent a knee revision due to prk due to instability.The initial surgery date is unknown.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
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,h6.The cmp was not confirmed.- no product was returned or pictures provided; visual and dimensional evaluations could not be performed.- review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified additional similar complaints for the reported items and no additional complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ap and lateral views of the left knee show changes of total knee arthroplasty with cemented components.There is no radiolucency around the components and the alignment is normal.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.

• Brand Name: PSN FEM CR CMT CCR NRW SZ 7 L
• 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 ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23810342
• Report Number: 3007963827-2025-00510
• Device Sequence Number: 21179402
• Product Code: MBH
• UDI-Device Identifier: 00889024229914
• UDI-Public: (01)00889024229914(17)301011(10)64823958
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42-5020-062-01
• Device Lot Number: 64823958
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• 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: Unknown