BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVE 11/13+0

    MDR report key: 2002897 · Received February 16, 2011

    Report

    Report Number
    1818910-2011-02439
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 17, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** 01/17/2011 - OPERATIVE REPORT FROM THE REVISION SURGERY REPORTS REVISION DUE TO METALLOSIS AND ACETABULAR MALPOSITION. IT IS FURTHER STATED IN THE OP REPORT THAT CORROSION WAS DISCOVERED AROUND THE ASR HEAD AND INO THE TRUNNION ON THE S-ROM STEM. THE S-ROM SLEEVE WAS WELL FIXED AND DID NOT SHOW ANY EVIDENCE OF CORROSION; IT WAS LEFT IMPLANTED. LOT NUMBERS WERE IDENTIFIED BY INVOICE SEARCH. EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER 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.

    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

    PT WAS REVISED TO ADDRESS HIP PAIN. OPERATIVE REPORT FROM THE REVISION SURGERY REPORTS REVISION DUE TO METALLOSIS AND ACETABULAR MALPOSITION. IT IS FURTHER STATED IN THE OP REPORT THAT CORROSION WAS DISCOVERED AROUND THE ASR HEAD AND INO THE TRUNNION ON THE S-ROM STEM. THE S-ROM SLEEVE WAS WELL FIXED AND DID NOT SHOW ANY EVIDENCE OF CORROSION; IT WAS LEFT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTER SLEEVE 11/13+0 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2291441

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention