BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR TAP SLV ADAP 12/14 -1

    MDR report key: 2914936 · Received January 15, 2013

    Report

    Report Number
    1818910-2013-00647
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    February 13, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K070359
    Removal / Correction Number
    Z-1749/1816-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    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. (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

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER LEG LENGTH DISCREPANCY RELATED REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. 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 PAPERS ALLEGE THE PATIENT SUFFERS FROM A NUMBER OF DIFFERENT COMPLAINTS INCLUDING PAIN, CLICKING OF THE IMPLANT COMPONENTS, AND CONSTANT DISCOMFORT. (B)(4) 2012 - PLAINTIFF FACT SHEET WAS RECEIVED. THE PRODUCT/LOT WAS UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. (B)(4) 2012 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION THREADING AROUND THE TRUNNION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21467 ASR TAP SLV ADAP 12/14 -1 SLEEVE KWA DEPUY INTERNATIONAL 2773010

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR