BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY/HEAD RADIAL ALTERNATE BEARING 56MM SHELL W/ APICAL PLUG

    MDR report key: 1951166 · Received January 6, 2011

    Report

    Report Number
    1825034-2011-00007
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    July 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K993438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION WAS DONE BY AN INDEPENDENT LAB THAT RECEIVED THE RETRIEVAL/IMPLANT. THE RETRIEVAL CENTER FORWARDED THEIR RESULTS TO BIOMET ORTHOPEDICS. THE DEVICE WAS NEVER MADE AVAILABLE TO BIOMET ORTHOPEDICS FOR EVALUATION. THE RETRIEVAL ANALYSIS RESULTS FORWARDED BY THE INDEPENDENT LAB DID NOT INDICATE A CLEAR CAUSE FOR THE OSTEOLYSIS; ALTHOUGH OBSERVATIONS WOULD SUGGEST THAT THE DEVICE WAS NOT THE CAUSE OF THE LYSIS. THIS REPORT FILED (B)(4), 2011.

    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 ONE STATES, "MATERIAL SENSITIVITY REACTIONS. IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT". (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2001. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2010, DUE TO PAIN AND OSTEOLYSIS. THE MODULAR HEAD, LINER, AND BEARING WERE ALL REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLORY/HEAD RADIAL ALTERNATE BEARING 56MM SHELL W/ APICAL PLUG PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 910150

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R