MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 9; PROSTHESIS, KNEE

Catalog Number	42500606601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Periprosthetic fracture (4902)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42512600712, articular surface fixed bearing constrained posterior stabilized (cps) left 12 mm height, lot 67098803 42540200029, all-poly patella cemented 29 mm diameter, lot 66815078 42545000510, tibial central cone size x-small, lot 66948841 42542007501, tibia fixed cemented left size f stem extension use required, lot 66435065 42560007514, stem extension tapered cemented 14 mm diameter +75 mm length, lot 67174924 g2: event occurred in australia.H6: proposed component code: mechanical (g04) - femur customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.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 2 months post implantation of a primary left total knee arthroplasty, the patient was revised of the femoral component and articular surface due to periprosthetic fracture.There was no reported trauma leading to the fracture.Attempts have been made and no additional information is available.
Event or Problem Description
No additional information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h3, h4, h6, h10 the reported event was unable to be confirmed with the information provided.Visual examination of the provided images reveals the explanted bearing and femoral component.Both devices don't appear to be damaged.However, especially on the femoral component, patient's tissue and blood can be seen covering the devices.No further assessment can be made.No medical records were provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 9
• 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 ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22902070
• Report Number: 3007963827-2025-00333
• Device Sequence Number: 18147115
• Product Code: JWH
• UDI-Device Identifier: 00889024229259
• UDI-Public: (01)00889024229259(17)350114(10)67038375
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/18/2025

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: 42500606601
• Device Lot Number: 67038375
• 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: 08/09/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female