BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM TAPER ADAPTER TYPE 1 TAPER 42-50MM HEAD SIZE -3MM

    MDR report key: 6110910 · Received November 17, 2016

    Report

    Report Number
    0001825034-2016-04731
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    September 29, 2014
    Report Date
    June 6, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES, INTRAOPERATIVE BONE PERFORATION OR FRACTURE MAY OCCUR, PARTICULARLY IN THE PRESENCE OF POOR BONE STOCK CAUSED BY OSTEOPOROSIS, BONE DEFECTS FROM PREVIOUS SURGERY, BONE RESORPTION, OR WHILE INSERTING THE DEVICE. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03736 / 03737 & 04731 / 04732).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: - M2A MAGNUM CUP, CATALOG#: US15784,8 LOT#: 150960. M2A MAGNUM HEAD, CATALOG#: 157442, LOT#: 617070. TAPERLOC STEM, CATALOG#: 103206, LOT#: 746740. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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 CONTRIBUTE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HIP PROCEDURE, THE FEMORAL HEAD WAS DIFFICULT TO REMOVE FROM THE STEM. DURING REMOVAL, A FEMORAL FRACTURE WAS NOTED. OSTEOTOMES WERE USED TO REMOVE THE FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761515 M2A-MAGNUM TAPER ADAPTER TYPE 1 TAPER 42-50MM HEAD SIZE -3MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 060720

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention