BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM ONE PIECE CUP SZ 56MM

    MDR report key: 4091797 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07699
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 18, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-07699 / 07700).

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND WAS FOUND TO HAVE BEEN MANUFACTURED WITHIN SPECIFICATIONS. A VISUAL EXAMINATION OF THE RECEIVED HEAD AND CUP APPEARED TO SHOW EVIDENCE OF SUBLUXATION OF THE JOINT, SCRATCHING OF THE BEARING SURFACES AND FRETTING OF THE HEAD TAPER. MEASUREMENTS WERE WITHIN THE NORMAL WEAR FOR AN IMPLANT THAT HAS BEEN IN FOR 7 YEARS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO ARMD AND MECHANICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573751 M2A 38MM ONE PIECE CUP SZ 56MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 049330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R