BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2895276 · Received January 3, 2013

    Report

    Report Number
    1818910-2013-00309
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    August 5, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE STEM/SLEEVE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED CORROSION WAS SAID TO HAVE BEEN WIPED OFF IN SURGERY. 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

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    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). 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

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

    Description of Event or Problem · 1

    UPDATE: - MEDICAL RECORDS RECEIVED (B)(6) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: LARGE METALLIC STAINED BURSA; MARKED NECROSIS AND ABSENCE OF THE EXTERNAL ROTATORS; SOME DESTRUCTION OF THE GLUTEUS MINIMUM; POSTERIOR CAPSULE WAS ABSENT AS WERE THE EXTERNAL ROTATORS. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE BILATERAL PATIENT SUFFERED FROM HIP PAIN, BACK AND GROIN PAIN, INABILITY TO STAND FOR LONG PERIODS OF TIME, DIFFICULTY WALKING, WALKED WITH A LIMP, BLURRINESS AND VISION PROBLEMS AND WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3231 ASR UNI FEMORAL IMPL SIZE 45 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2005208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other