BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 41

    MDR report key: 2161912 · Received July 11, 2011

    Report

    Report Number
    1818910-2011-12523
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 14, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: PATIENT WAS REVISED TO ADDRESS PAIN AND ACETABULAR LOOSENING. DOI: (B)(6) 2006 - DOR: (B)(6) 2011 (LEFT SIDE). UPDATE: (B)(6) 2011 - MEDICAL RECORDS RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THAT LEUKOCYTIC JOINT FLUID WITH WHITE MILKY CHARACTERISTIC WAS OBSERVED INTRAOPERATIVELY. COMPLAINT REOPENED TO ADD THE FEMORAL HEAD. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND ACETABULAR LOOSENING. UPDATE (B)(6) 2011 - MEDICAL RECORDS RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THAT LEUKOCYTIC JOINT FLUID WITH WHITE MILKY CHARACTERISTIC WAS OBSERVED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 41 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2177767

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention