BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 4133897 · Received October 2, 2014

    Report

    Report Number
    1818910-2014-29246
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 16, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (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. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH RECEIVED. DESCRIBE EVENT OR PROBLEM: PATIENT HAD SURGERY FOR FAILED RIGHT TOTAL HIP REPLACEMENT DUE TO ARTICULAR WEAR (ASR RECALLED HIP). IMPLANTS WERE REMOVED AND REPLACED WITH NEW IMPLANTS. HARDWARE DESCRIPTION: FEMORAL HEAD 999890245; 2201814, 45. ACETABULAR CUP DP 2160688 C SIZE 50. OTHER RELEVANT HISTORY MARKED ELEVATION OF COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615549 ASR UNI FEMORAL IMPL SIZE 45 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2201814

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention