BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS-K 17CM DIAPH SEG SMOOTH

    MDR report key: 19867400 · Received July 30, 2024

    Report

    Report Number
    0001825034-2024-01938
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    February 27, 2024
    Report Date
    July 30, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K123501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 MEDICAL DEVICES: OSS FINN MOD PROXIMAL FEMORAL RIGHT 7CM CATALOG#: 150457 LOT#: 463260. FREEDOM CONSTR HD 36MM T1 +6MM CATALOG#: 11-107020 LOT#: 608650. FREEDOM STD FACE LINER SZ 25 CATALOG#: 11-107324 LOT#: 256310. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE THREADED PORTION OF THE SEGMENT IS FRACTURED AND A PORTION OF THE FRACTURED DEVICE WAS LEFT IN THE PROXIMAL FEMUR. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. ROOT CAUSE WAS 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

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO IMPLANT FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199036 OSS-K 17CM DIAPH SEG SMOOTH PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 480730

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Hospitalization| R