BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK

    MDR report key: 15300684 · Received August 26, 2022

    Report

    Report Number
    0001822565-2022-02365
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    July 29, 2022
    Report Date
    August 11, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024131651
    PMA / PMN Number
    K060040
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:11-301304 LOT NUMBER:088460 BRAND NAME: ARCOS. CATALOG NUMBER: 11-300822 LOT NUMBER:743990 BRAND NAME: ARCOS. CATALOG NUMBER: 010001036 LOT NUMBER:7017244 BRAND NAME: COCR HEAD. CATALOG NUMBER: 00877504002 LOT NUMBER: 2980791 BRAND NAME: BIOLOX DELTA HEAD. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE COULD NOT BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481901 FEMORAL STEM 12/14 NECK PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64237962 00889024131651

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H