MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN FEM CR CMT CCR NRW SZ 9 R; PROSTHESIS, KNEE

Catalog Number	42502006602
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	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: part # 42522100810, articular surface medial congruent (mc) right 10 mm height use with tibia sizes e-f/cr femur sizes 8-11, lot # 64981181.Part # 42532007102, tibia cemented 5 degree stemmed right size e, lot # 64979533.Part # 42557000114, stem extension tapered cemented 14 mm diameter +30 mm length, lot # 65216923.H6: suggested component code: mechanical (g04) - femur.Customer has indicated that the product is in process of being 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 that approximately 3.5 years post implantation of a right knee arthroplasty, the patient returned to the doctor for complaints of pain.Bone scan identified loosening of the femur.Subsequently, the patient was revised of all components.Attempts for additional information were made and none is available.
Event or Problem Description
No further event information 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; d9; g1; g3; g6; h1; h2; h3; h6.The event cannot be confirmed.Visual examination of the returned product identified signs of being implanted scratched with foreign material adhered to the surface.Dimensional analysis of the product determined that the product, where measured, was conforming to its print specifications.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.X-rays were provided and reviewed by a healthcare professional.Imaging revealed showed a new mild radiolucency at the bone cement interface deep to the anterior femoral flange.The impression noted that the lucency was indeterminate and that although the finding could predispose to loosening, there was no gross radiographic evidence of femoral component loosening on the limited available views.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.

• Brand Name: PSN FEM CR CMT CCR NRW SZ 9 R
• 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: 22639326
• Report Number: 3007963827-2025-00294
• Device Sequence Number: 9564073
• Product Code: MBH
• UDI-Device Identifier: 00889024229969
• UDI-Public: (01)00889024229969(17)291130(10)64432478
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42502006602
• Device Lot Number: 64432478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2019
• 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