BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 4090156 · Received September 15, 2014

    Report

    Report Number
    1818910-2014-28025
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    May 10, 2010
    Report Date
    October 21, 2014
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. 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. WWCAPA (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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED DUE TO HAVING SEVERE OSTEOPOROSIS AND LATER DEVELOPED A PELVIC DISCONTINUITY WITH THE CUP WANDERING IN ONTO THE BLADDER. DURING THIS REVISION OPERATION METALLOSIS WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568523 ASR UNI FEMORAL IMPL SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. ¿ REG. # 8010379 2887965

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention