MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW RIGHT SIZE 7; PROSTHESIS, KNEE

Catalog Number	42502006202
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Implant subsidence (4078)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42-5020-062-02, persona cr cemented femur, (b)(6).42-5220-004-10, persona right cr cd 10mm art surface, (b)(6).42-5402-000-32, persona all poly patella 32mm, (b)(6).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.
Event or Problem Description
It was reported the patient underwent an initial knee surgery.Subsequently about 2.5 years later they had a revision due to tibial component loosening with subsidence; the femoral component was also found to be loose.The patient had multiple prior surgeries on the knee before the index knee replacement, including an acl procedure.The patient experienced increasing pain and subsequently sustained a fall, after which pain further increased and was reported to the surgeon.During the revision procedure, frozen sections were taken and showed no neutrophils.Biopsy and cultures to date have not grown organisms.The diagnosis was aseptic loosening.No further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5;d1; d2; d4; g1; e2; g3; g6; h1; h2; h3; h6.H6: proposed component code: mechanical (g04) - femur.The reported event was confirmed.Visual examination of the provided photograph identified explanted femoral, tibial and articular surface components.All devices were covered in bio-debris.Part and lot information were not identifiable from the photo provided.No devices were returned therefore no further evaluations can be made.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: unremarkable right knee arthroplasty on the initial visit.Follow-up ap and lateral views of the right knee show new lucency at the bone cement interface around the medial tibial tray and tibial stem and mild posterior subsidence of the tibial component although no prior lateral radiographs are available for comparison.No gross radiolucency around the cemented femoral or patellar components.Small to moderate knee joint effusion noted.Loosening and subsidence of the tibial component.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW RIGHT SIZE 7
• 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: 23872516
• Report Number: 3007963827-2025-00531
• Device Sequence Number: 5331060
• Product Code: MBH
• UDI-Device Identifier: 00889024229921
• UDI-Public: (01)00889024229921(17)330318(10)65702118
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• 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): 03/13/2026

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: 42502006202
• Device Lot Number: 65702118
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 66 KG