BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPAEDIC SALVAGE SYSTEM TIBIAL POLY BEARING 12MM

    MDR report key: 19853843 · Received July 29, 2024

    Report

    Report Number
    0001825034-2024-01925
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    July 4, 2024
    Report Date
    December 31, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    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 - CONCOMITANT DEVICES - ORTHOPAEDIC SALVAGE SYSTEM NON-MONDULAR TIBIAL PLATE LONG 67 CATALOG #: 150420 LOT #: 829330, ORTHOPAEDIC SALVAGE SYSTEM FINN MODULAR PROXIMAL FEMORAL COMPONENT RIGHT 7CM CATALOG #: 150457 LOT #: 254810, ORTHOPAEDIC SALVAGE SYSTEM DIAPHYSEAL SEGMENT 17CM CATALOG #: 150471 LOT #: 586800, ORTHOPAEDIC SALVAGE SYSTEM FEMORAL DIAPHYSEAL CALIPER 10CM CATALOG #: 150462 LOT #: 336420, ORTHOPAEDIC SALVAGE SYSTEM SEGMENTAL FEMORAL COMPONENT RIGHT 7CM CATALOG #: 150354 LOT #: 729270, ORTHOPAEDIC SALVAGE SYSTEM AXLE CATALOG #: 150480 LOT #: 430150, ORTHOPAEDIC SALVAGE SYSTEM POLY LOCKING PIN CATALOG #: 150478 LOT #: 913730, ORTHOPAEDIC SALVAGE SYSTEM POLY TIBIAL BUSHING CATALOG #: 150476 LOT #: 007150, ORTHOPAEDIC SALVAGE SYSTEM REINFORCED YOKE CATALOG #: 150493 LOT #: 984900, ORTHOPAEDIC SALVAGE SYSTEM POLY FEMORAL BUSHINGS CATALOG #: 150477 LOT #: 013150, FREEDOM CONSTRAINED HEAD 36MM CATALOG #: 11-107018 LOT #: 942230, FREEDOM CONSTRAINED LINER +5 SIZE 23 CATALOG #: 11-107022 LOT #: 192404. G2 - REPORT SOURCE - FOREIGN: EVENT OCCURRED IN AUSTRALIA. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. 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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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: THE RIGHT KNEE ARTHROPLASTY ALIGNMENT IS MAINTAINED DESPITE THE REPORTED BEARING FRACTURE. THERE IS SUBSIDENCE OF THE TIBIAL IMPLANT AND RADIOLUCENCY ALONG THE TIBIAL STEM REFLECTING IMPLANT LOOSENING AND CONTOUR DEFORMITY OF THE MEDIAL TIBIAL DIAPHYSIS. THE TIBIAL IMPLANT LOOSENING AND SUBSIDENCE IS CONFIRMED. THE FRACTURED BEARING IS NOT VISIBLE ON THE RADIOGRAPHS. 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 THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS TIBIAL COMPONENT LOOSENING AND POST-OPERATIVE FRACTURE OF THE ARTICULAR SURFACE APPROXIMATELY TEN (10) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    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
    994362 ORTHOPAEDIC SALVAGE SYSTEM TIBIAL POLY BEARING 12MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 288740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11 NARRATIVE.