BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACET IMP 48

    MDR report key: 1983452 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-00091
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 3, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. 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 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).

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH ASR PRODUCTS ON (B)(6) 2006, TO TREAT COXARTHROSIS. FOLLOWING THE ONSET OF PAIN AT LEFT HIP, THE PATIENT WAS REVISED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACET IMP 48 TOTAL HIP REPLACEMENT JDI DEPUY INTERNATIONAL, LTD NA 1221587

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention