BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A TPR HI CARBON 41/32MM LINER

    MDR report key: 2955223 · Received February 11, 2013

    Report

    Report Number
    0001825034-2013-00249
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00248 / 00250).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2009, ALLEGEDLY DUE TO DISLOCATION. THE HEAD WAS REMOVED AND REPLACED WITH ANOTHER BIOMET HEAD. A FURTHER REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013, ALLEGEDLY DUE TO DISLOCATION CAUSED BY PSEUDOTUMOR. THE HEAD, CUP AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58291 M2A TPR HI CARBON 41/32MM LINER PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 536590

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R