BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2012660 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-02804
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(6) 2012 - PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DATE OF REVISION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. 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

    THE REPORT STATES: BILATERAL PATIENT WAS REVISED TO ADDRESS CHRONIC PAIN. OSTEOLYSIS WAS REPORTED. DOI (B)(6) 2008 - DOR (B)(6) 2011 (RIGHT HIP). UPDATE (B)(6) 2011 - LITIGATION PAPERS ALLEGE THE PATIENT WAS BILATERAL. IT IS FURTHER ALLEGED THAT THE LEFT HIP WAS ALSO REVISED (IN (B)(6)) DUE TO SEVERE PAIN AND DISCOMFORT IN HIS LEFT AND RIGHT THIGHS, GROIN, KNEES, HIP-JOINTS, AND BACK; INABILITY TO BEND OVER COMFORTABLY; INABILITY TO WALK WITHOUT SEVERE PAIN AFTER A FEW MINUTES; FEELING THAT LEGS ARE UNSTABLE WHEN STANDING-UP AND THAT HIPS WILL GIVE OUT; SEVERE METALLOSIS DAMAGING THE BONE AND TISSUE SURROUNDING THE IMPLANTS; OTHER INFECTION AND INFLAMMATION OF SURROUNDING BONE AND TISSUE; SWELLING; AND CHROMIUM AND COBALT METAL TOXICITY. DOI: (B)(6) 2008 - DOR: (B)(6) 2011 (LEFT HIP). UPDATE (B)(6) 2011 - THE REVISION FOR THE PATIENTS LEFT HIP WAS REPORTED BY THE SALES REPRESENTATIVE. IT WAS REPORTED THAT THERE WAS NO NOTICEABLE DISCOLORING OF THE SOFT TISSUE OR WEAR. THE CUP APPEARED TO BE WELL FIXED AND THERE DID NOT APPEAR TO BE ANYTHING RADIOGRAPHICALLY. THE PATIENT CLAIMED TO HAVE SOME DISCOMFORT. DOR: (B)(6) 2011 (LEFT HIP). 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.

    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 CHRONIC PAIN. OSTEOLYSIS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2492045

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention