BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2213380 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-15191
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    January 20, 2015
    Report Date
    May 1, 2015
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    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.DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.(B)(4)

    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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED. (B)(4).

    Description of Event or Problem · 1

    BILATERAL PT. LITIGATION PAPERS ALLEGE PT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES: PAST MEDICAL EXPENSES, FUTURE MEDICAL EXPENSES, PAST LOST WAGES, FUTURE LOST WAGES, PAST AND FUTURE CONSCIOUS PAIN AND SUFFERING, PHYSICAL INJURY, BODILY IMPAIRMENT, MENTAL ANGUISH, EMOTIONAL DISTRESS AND LOSS OF ENJOYMENT OF LIFE. PT HAS NOT YET SCHEDULED AN EXPLANTATION OF EITHER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE REC'D 5/1/2015 - PPD WITH MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS DYSFUNCTION AND METALLOSIS. UPON REVISION, METAL STAINING WAS NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON 05/26/15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2464134

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention