MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN FEM PS CMT CCR STD SZ 8 L; PROSTHESIS, KNEE

Catalog Number	42500606401
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee revision approximately 3 years and 11 months post-implantation due to pain and loosening.The primary posterior-stabilized knee components were revised to a revision knee system.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: pn: 42532007501, ln: 649655598, psn tib stm 5 deg sz f.Suggested component code: mechanical (g04) ¿ femur.G2: foreign - event occurred in australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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; d4; g3; h2; h4; h6.\ \ \ 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.\ \ these devices are used for treatment.\ \ 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.\ \ x-rays were provided and reviewed by mmi they state that total knee arthroplasty exhibits loosening of the tibial component associated with subsidence and exaggerated posterior tilt of the tibial tray.Identified risk factors for tibial component loosening include generalized reduced bone mineral density and sparse cement mantle.\ suspect loosening of the femoral component.The suprapatellar pouch is distended with thick radio dense synovial lining with scattered radiodense debris at the joint lining suspicious for metallosis.\ \ a definitive root cause cannot be determined.\ \ no corrective actions, preventive actions, or field actions resulted after investigation of this event.\ \ complaint is confirmed\ \ 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 further event information is available at the time of this report.

• Brand Name: PSN FEM PS CMT CCR STD SZ 8 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: 25346966
• Report Number: 3007963827-2026-00226
• Device Sequence Number: 20110829
• Product Code: JWH
• UDI-Device Identifier: 00889024229235
• UDI-Public: (01)00889024229235(17)301021(10)64831672
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• 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): 07/21/2026

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: 42500606401
• Device Lot Number: 64831672
• 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: 05/08/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H1; SEE H1.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 207 LB