BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 3023306 · Received March 27, 2013

    Report

    Report Number
    1818910-2013-04129
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT WAS REVISED DUE TO PAIN AND STIFFNESS. THE PATIENT WAS HAD PERSISTENT PAIN WITH HIP FLEXION, IMPINGEMENT OF THE ILLIOPSOAS TENDON DUE TO A LARGE FEMORAL HEAD. THE RADIOGRAPHIC EVALUATION REVEALED THE CUP TO BE ANTERVERTED WITH 40 ANGLE OF INCLINATION. ALSO NOTED WAS A CYST IN THE 'CARNLEY AND DE LEE ZONE'. (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125687 ASR ACETABULAR CUPS 60 SHELL KWA DEPUY INTERNATIONAL 2142043

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other