BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2945473 · Received February 6, 2013

    Report

    Report Number
    1818910-2013-01288
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    July 19, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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).

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HAS BEEN REOPENED BECAUSE PRODUCT INFORMATION HAS BEEN RECEIVED WHICH MAY CHANGE THE INVESTIGATION FOR THE STEM.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE FEMORAL STEM PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. IT IS KNOWN 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

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(6) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: PAIN; EROSION; METAL STAINING; LOOSE STEM; METAL STAINED DEBRIS; GRANULOMATOUS AND METAL DEBRIS TISSUE. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2013 -SALES REP REPORTED REVISION SURGERY ON RIGHT HIP DUE TO PAIN AND STEM LOOSENING.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, GRINDING, CLICKING AND POPPING OF HIS HIP JOINT, DIFFICULTY WALKING, INSTABILITY, PHYSICAL LIMITATIONS, PERMANENT DISABILITY AND DISFIGUREMENT, AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50144 ASR ACETABULAR CUPS 56 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2539339

    Patients

    Seq Age Sex Outcome Treatment
    1 Other