MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA TIBIA CEMENTED 5 DEGREE STEMMED; PROSTHESIS KNEE

Catalog Number	42532006701
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: all-poly patella cemented 29 mm diameter catalog # 42540200029 lot # 65061512, biomet bc r 1x40 us catalog # 110035368 lot # ay08ac1504, quick-vac mixing bowl single catalog # 00504900100 lot # 56518553, 2.5 mm female hex screw 25 mm length catalog # 42509902525 lot # 65170106, femur cemented cruciate retaining (cr) narrow left size 6 catalog # 42502006001 lot # 65002373, articular surface fixed bearing ultracongruent (uc) left 11 mm height catalog # 42512200411 lot # 64954336.H3: 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 patient underwent a revision procedure three years post implantation due to tibial loosening.Attempts to obtain additional information have been made; however, no more is available.
Event or Problem Description
It was reported that a patient underwent a revision procedure three years post implantation due to pain, instability, and tibial loosening.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d5; d9; g3; h2; h3; h4; h6; h11.Visual examination of the returned product identified signs of use (gouges, bone cement remains) and also the articular surface remains assembled.Dimensional analysis of the product determined that the product, where measured, was conforming to its print specifications.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a healthcare professional.They state that the left total knee arthroplasty demonstrates radiolucency surrounding the tibial with posterior subsidence of the tibial component.The cement mantle was found to be minimal anteriorly along the tibial.Prepatellar edema was also observed.The imaging findings are consistent with loosening of the tibial component.Root cause was unable to be determined.Reported event was confirmed by review of provided radiographs.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 TIBIA CEMENTED 5 DEGREE STEMMED
• 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: 21691256
• Report Number: 3007963827-2025-00110
• Device Sequence Number: 8730958
• Product Code: MBH
• UDI-Device Identifier: 00889024471030
• UDI-Public: (01)00889024471030(17)310513(10)65020542
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: 42532006701
• Device Lot Number: 65020542
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 73 KG