BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 1933635 · Received December 17, 2010

    Report

    Report Number
    1818910-2010-09957
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    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

    THE REPORT STATES: PATIENT REVISED FOR PAIN, FOUND LOOSE MALPOSITIONED CUP AND HIGH ION LEVEL. DOI (B)(6) 2006 DOR (B)(6) 2010 (RIGHT HIP). UPDATE (B)(4) 2011 - MEDICAL RECORDS WERE RECEIVED. THE TRUNION OF THE FEMORAL STEM WAS NOTED TO HAVE SOME CORROSION AND IT WAS FELT THAT THE FEMORAL STEM NEEDED TO BE REMOVED. IT TOOK APPROX. TWO HOURS TO DISASSEMBLE THE FEMORAL STEM FROM THE SLEEVE. THE FEMORAL STEM, SLEEVE AND ADAPTER SLEEVE WERE ADDED TO THE COMPLAINT. 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.

    Description of Event or Problem · 1

    PATIENT REVISED FOR PAIN, FOUND LOOSE MALPOSITIONED CUP AND HIGH ION LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 49 87KWA KWA DEPUY INTERNATIONAL, LTD NA 2164318

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention