BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM RS LS TIBIAL BEARING 14MM

    MDR report key: 10896070 · Received November 24, 2020

    Report

    Report Number
    0001825034-2020-04176
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    November 2, 2020
    Report Date
    March 17, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE PROVIDED PICTURE FOUND THE YOKE TABS HAVE FRACTURED OFF AND THE BEARING HARD FRACTURED NEAR THE YOKE TABLES. THERE IS ALSO METALLOSIS SEEN IN THE JOINT SPACE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM YOKE CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM LOCK PIN CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM AXLE CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHINGS CATALOG #: NI LOT #: NI, UNKNOWN SCREWS CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM FEMORAL COMPONENT CATALOG #: NI LOT #: NI, ORTHOPEDIC SALVAGE SYSTEM 7CM DIAPHYSEAL SEGMENT CATALOG #: 150466 LOT #: NI, ORTHOPEDIC SALVAGE SYSTEM MODULAR PROXIMAL TIBIAL BODY 9CM CATALOG #: 161027 LOT #: NI, ORTHOPEDIC SALVAGE SYSTEM FEMORAL DIAPHYSEAL COUPLER 30CM CATALOG #: 150463 LOT #: NI. REPORT SOURCE - FOREIGN: (B)(6). THE COMPLAINANT HAS NOT YET INDICATED WHETHER THE DEVICE WILL BE RETURNED TO ZIMMER BIOMET FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2020-04176, 0001825034-2020-04180.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE METALLOSIS AND IMPLANT FRACTURE OF THE YOKE AND TIBIAL BEARING APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355234 ORTHOPEDIC SALVAGE SYSTEM RS LS TIBIAL BEARING 14MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 426400

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE