BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE C

    MDR report key: 23872519 · Received December 22, 2025

    Report

    Report Number
    3007963827-2025-00532
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 26, 2025
    Report Date
    March 13, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024471023
    PMA / PMN Number
    K172524
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 42-5020-062-02, PERSONA CR CEMENTED FEMUR, 65702118. 42-5220-004-10, PERSONA RIGHT CR CD 10MM ART SURFACE, 65897423. 42-5402-000-32, PERSONA ALL POLY PATELLA 32MM, 65777305. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - FEMU. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D1; D2; D4; E2; G1; G3; G6; H1; H2; H3; H6. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. 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. 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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11368 PERSONA TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE C PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 65363312 00889024471023

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Hospitalization| R SEE H11.