BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 2000399 · Received February 10, 2011

    Report

    Report Number
    1818910-2011-01984
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    September 9, 2009
    Report Date
    January 11, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(4) 2011 - MEDICAL RECORDS RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THAT THE POST-OP DIAGNOSIS AS LOOSE ACETABULAR COMPONENT. NOTES CONTAINED WITHIN THE RECORDS MENTION A BROWNISH FILMY MEMBRANE INSIDE THE PROSTHETIC HEAD. THE COMPLAINT WAS UPDATED. DOI: (B)(6) 2009. 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 OF THE ACETABULAR COMPONENT. NOTES CONTAINED WITHIN THE PT'S MEDICAL RECORDS MENTION A BROWNISH FILMY MEMBRANE INSIDE THE PROSTHETIC HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 53 87KWA KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention