BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 44

    MDR report key: 2112600 · Received May 19, 2011

    Report

    Report Number
    1818910-2011-08795
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    October 7, 2013
    Report Date
    June 24, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: REPORTING NUMBER. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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. EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS ONE OTHER UNRELATED REPORT AGAINST THE PRODUCT/LOT CODE COMBINATION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED.

    Description of Event or Problem · 1

    UPDATE: 3/31/2014 - PPD WITH MEDICAL RECORDS RECEIVED. PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2013. UPON REVISION, MINIMAL CORROSION AT THE HEAD AND NECK JUNCTION WAS NOTED. THE RIGHT HIP STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6), 2006, PT WAS IMPLANTED WITH A DEPUY ASR XL ACETABULAR HIP WITH A SUMMIT STEM ON HER LEFT SIDE. ON OR ABOUT (B)(6), 2007, PT WAS IMPLANTED WITH A DEPUY ASR XL ACETABULAR HIP ON HER RIGHT SIDE. SINCE THE SURGICAL IMPLANTATIONS, PT HAS EXPERIENCED SWELLING, PAIN, POPPING, GRINDING, AND PROBLEMS WITH MOBILITY. ADDITIONALLY, IT IS ALLEGED THAT PT WILL POTENTIALLY NEED REVISION SURGERY IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 44 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 1960337

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention