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

Catalog Number	42502606602
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42522100912: articular surface medial congruent (mc) right 12 mm height use with tibia sizes g-h/cr femur sizes 8-11: 65063106.42532007902: tibia cemented 5 degree stemmed right size g: 65434017.42540200038: all-poly patella cemented 38 mm diameter: 65671691.H6: mechanical (g04): femur.Product has been received by zimmer biomet and 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 the patient underwent an initial right knee surgery.Approximately 3 years post-op, the patient was revised due to femoral loosening.The patient was revised to a different system.Attempts have been made and all available information has been provided.
Event or Problem Description
It was further reported that during the revision, the femoral component was tapped free, with a fair amount of bone loss observed due to aseptic loosening and gradual degradation of the distal femur.The tibial component was better fixed and was removed with minimal bone loss.Femoral, tibial, and polyethylene components were revised without complications.The patella component was noted to be in good condition and therefore retained.Attempts have been made and all available 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; d2; g1; g3; g6; h1; h2.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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; g1; g3; g6; h1; h2; h3; h4; h6.The event is confirmed.Visual examination of the returned product identified signs of implantation (scratches).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.Medical records provided and reviewed state that the patient underwent an initial right total knee arthroplasty and no intraoperative complications were documented.Subsequent records indicate that the patient underwent revision of the right knee at due to reported femoral loosening.Intraoperatively, the patellar component was found to be in good condition and was therefore retained.The femoral component was tapped free with a fair amount of bone loss, which was described as being due to aseptic loosening and gradual degradation of the distal femur.No intraoperative complications were reported.X-rays were provided and reviewed by a healthcare professional state that the femoral component is oversized, misaligned and probably loose.The tibial component is also misaligned and possibly loose with possible osteolysis of the lateral tibial plateau.Moderate knee joint effusion.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: PERSONA FEMUR CEMENTED CRUCIATE RETAINING (CR)
• 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: 24673954
• Report Number: 3007963827-2026-00115
• Device Sequence Number: 10101708
• Product Code: MBH
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2026

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: 42502606602
• Device Lot Number: 65403354
• Date Returned to Manufacturer: 03/16/2026
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 06/29/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/08/2026; 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 177 LB