BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 2933774 · Received January 29, 2013

    Report

    Report Number
    1818910-2013-02028
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    September 25, 2014
    Report Date
    November 26, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, DISABILITY AND WAS PHYSICALLY DAMAGED FROM EXPOSURE TO CHROMIUM AND COBALT AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE REC¿D (B)(6) 2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS CUP LOOSENING AND METALLOSIS. UPON REVISION, GOLDEN CLEAR FLUID, BLACK TISSUE STAINING, FOREIGN BODY-LIKE GRANULOMATOUS REACTIVITY, AND CORROSION AT THE TRUNNION WERE NOTED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THE STEM REMAINED IN SITU. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39315 ASR ACETABULAR CUPS 48 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2596542

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other