BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2012611 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-02857
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS CUP LOOSENING. PATIENT WAS REVISED TO ADDRESS CUP LOOSENING. THERE WAS SOME ANTERIOR BONE INGROWTH. DOI (B)(6) 2007 - DOR (B)(6) 2011 (RIGHT HIP). UPDATE (B)(4) 2011 - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT STATES THAT THE ACETABULAR CUP WAS NOT LOOSE, BUT WAS SOLIDLY FIXED. CLINICAL HISTORY NOTES REPORT THAT THE PATIENT WISHED TO UNDERGO REVISION SURGERY DUE TO PAIN AND DISCOMFORT. LAB REPORT REFLECTS ELEVATED COBALT AND CHROMIUM LEVELS. THE COMPLAINT WAS REOPENED TO ADD THE FEMORAL HEAD. UPDATE (B)(4) 2012 - LITIGATION PAPERS WERE RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. 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 CUP LOOSENING. THERE WAS SOME ANTERIOR BONE INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2422954

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention