BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR TAPERLOC FEMORAL POROUS COATED 7.5 X 135MM TYPE I TAPER

    MDR report key: 6739675 · Received July 25, 2017

    Report

    Report Number
    0001825034-2017-05176
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    May 22, 2014
    Report Date
    September 18, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).US157856 964770 M2A-MAGNUM PF CUP 56ODX50ID. 157450 262260 M2A-MAGNUM MOD HD SZ 50MM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 · 1

    IT WAS REPORTED PATIENT¿S LEFT HIP WAS REVISED APPROXIMATELY 4 YEARS POST-IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    REVIEW OF THE OP NOTES RECEIVED 05/22/2014, IT WAS NOTED THAT "DURING THE REMOVAL OF THE WELL SEATED STEM, THERE WAS SOME DAMAGE TO THE ANTERIOR CORTEX OF THE FEMUR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521293 MODULAR TAPERLOC FEMORAL POROUS COATED 7.5 X 135MM TYPE I TAPER PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 788340

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R SEE H10 NARRATIVE