BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2071632 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06676
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    August 14, 2012
    Report Date
    August 16, 2012
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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. (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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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

    LITIGATION PAPERS ALLEGE THE BILATERAL PATIENT SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SORENESS AND DIFFICULTY WALKING. UPDATE MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS INDICATE LEFT SIDE WAS REVISED. HETEROTOPIC OSSIFICATION WAS NOTED DURING THE REVISION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE BILATERAL PATIENT SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SORENESS AND DIFFICULTY WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL, LTD. NA 2516200

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention