MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEM CR CMT CCR NRW; PROSTHESIS KNEE

Catalog Number	42502005801
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: articular surface medial congruent (mc) left 13 mm height use with tibia sizes c-d/cr femur sizes 4-5 catalog # 42512100313 lot # 65580509.All poly petella standard cemented size 29 mm diameter 8.0 mm thickness catalog # 00597206529, lot # 65840350.Stem extension tapered cemented 14 mm diameter +30 mm length catalog # 42557000114, lot # 65996857.Tibia cemented 5 degree stemmed left size c catalog # 42532006401, lot # 65850326 biomet bc r 1x40 us catalog # 110035368, lot # aw02ab0602.H6: mechanical (g04) - femur.H3: the complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure eighteen years post implantation due to femoral loosening.No more information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, and h11.Corrected: h4.Visual examination of the returned psn cr narrow cemented femur identified signs of being implanted wear, scratches with foreign material adhered to the condyle.The psn mc ve articular surface was also returned and visual examination identified signs of being implanted (wear/scratches/gouges).Dimensional analysis of the product determined that the product, where measured, was conforming to its print specifications.Medical records provided and reviewed state that the patient underwent a left total knee arthroplasty.The patient was revised due to loosening of the femoral implant.Imaging included a lateral knee x-ray, which showed standard sagittal alignment of the cemented components and a low-lying patella.There was limited cement visualized in knee society femoral zones 1 and 2, and tibial zones 3a and 4a.Artifactual radiolucent lines were noted at the femoral and tibial bone-soft tissue, metal-soft tissue, metal-bone, and cement-bone interfaces.These imaging findings could neither confirm nor rule out prosthetic component loosening.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.This complaint is not 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.H6: component code: proposed component (annex g) code is: - mechanical (g04) ¿ femur.

• Brand Name: PERSONA FEM CR CMT CCR NRW
• 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: 21696467
• Report Number: 3007963827-2025-00111
• Device Sequence Number: 9308128
• Product Code: JWH
• UDI-Device Identifier: 00889024229877
• UDI-Public: (01)00889024229877(17)330106(10)65594368
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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?: Yes
• Device Catalogue Number: 42502005801
• Device Lot Number: 65594368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 54 KG