BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2211688 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-14525
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    November 16, 2010
    Report Date
    August 21, 2013
    Manufacturer
    DEPUY INTL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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

    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 LOOSENING. UPDATE: (B)(6) 2011 - LITIGATION PAPERS ALLEGE, PT SUFFERED SEVERE PAIN, SORENESS, AND DISCOMFORT; DIFFICULTY SLEEPING, WALKING, STANDING FOR PROLONGED PERIODS OF TIME, AND PERFORMING ROUTINE ACTIVITIES; SIGNIFICANT WEIGHT LOSS, LEFT ILIOPSOAS MUSCLE FLUID COLLECTION LEADING TO INCREASING PAIN, SWELLING AND DEEP VEIN THROMBOSIS; INABILITY TO LEAD A NORMAL LIFE; ELEVATED METAL IONS LEVELS, MEASURED AT 7.8 MCG/L OF COBALT PRE-REVISION; REVISION SURGERY REVEALING LOOSE ASP CUP; EMOTIONAL DISTRESS, ANXIETY AND MENTAL ANGUISH; MEDICAL AND OTHER RELATED EXPENSES. FEMORAL HEAD ADDED TO COMPLAINT.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: SMALL AVULSION TYPE INJURY OF THE GLUTEUS MEDIUS; SIGNIFICANT AMOUNT OF FLUID AND IRRITABLE APPEARING GRANULATION TYPE TISSUE THROUGHOUT THE PSEUDOCAPSULE AREA; CUP WAS SEEMINGLY LOOSE AS IT CAME OUT WITH NO BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 87KWA KWA DEPUY INTL, LTD NA 2783220

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention