BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 46

    MDR report key: 2801475 · Received October 23, 2012

    Report

    Report Number
    1818910-2012-23838
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 4, 2013
    Report Date
    November 13, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEPUY STILL CONSIDERS THIS INVESTIGATON CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM PAIN, ELEVATED METAL ION LEVELS, DISFIGUREMENT, PHYSICAL IMPAIRMENT AND EMOTIONAL STRESS.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2013, MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO CHRONIC MECHANICAL COMPLICATIONS, MILKY FLUID IN THE HIP CAPSULE, ACUTE INFLAMMATION, OSTEOLYSIS, AND FRETTING AT THE JUNCTION OF THE FEMORAL HEAD AND SROM TRUNNION. THE SROM STEM AND SROM SLEEVE REMAINED IN SITU. THE ASR SLEEVE, SROM STEM AND SROM SLEEVE HAVE BEEN ADDED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 46 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2165155

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other