BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY METAL LINER

    MDR report key: 3022410 · Received March 27, 2013

    Report

    Report Number
    1818910-2013-04335
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT 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

    BILATERAL PATIENT: LEGAL CLAIM ALLEGES PATIENT HAS UNDERGONE SURGICAL INTERVENTIONS IN RESPECT OF BOTH HER LEFT AND RIGHT HIP. IT IS FURTHER ALLEGED SUBSEQUENT THERETO, EACH HIP SUFFERED SEVERAL DISLOCATIONS. IT IS FURTHER ALLEGED PURSUANT TO THE MULTIPLE SURGERIES AND DISLOCATIONS, SHE HAS SUFFERED A GREAT DEAL AND HAS BEEN ON PAIN REDUCING MEDICATION THROUGHOUT THE PROCESS, COMMENCING IN 2003. **UPDATE** (B)(6) 2013 - THE COMPLAINT HAS BEEN REOPENED BECAUSE, PER THE AFFILIATE, IT WAS REPORTED VIA LEGAL NOTICE THAT THE PATIENT'S LEFT HIP, ORIGINALLY IMPLANTED ON (B)(6) 2003, WAS REVISED ON (B)(6) 2003 DUE TO RECURRENT DISLOCATION AND AGAIN ON (B)(6) 2011 DUE TO RECURRENT DISLOCATION AND INSTABILITY, AND THAT SIGNIFICANT METALLOSIS WAS FOUND, AS WELL AS A LARGE CYST IN THE POSTERIOR ASPECT OF THE FEMUR, APPROXIMATELY 5X3X2CM, FILLED WITH METAL DEBRIS. PATIENT ALSO REPORTEDLY EXPERIENCED UNEXPLAINABLE PAINS IN SEVERAL AREAS OF HER BODY OUTSIDE THE HIP AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127242 UNKNOWN DEPUY METAL LINER ACETABULAR LINER KWA DEPUY WARSAW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention