BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR CUP

    MDR report key: 2863943 · Received December 10, 2012

    Report

    Report Number
    1818910-2012-29153
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. . IT IS KNOWN THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION HAS NOT BEEN INDICATED. 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

    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 WAS REVISED DUE TO CUP AND STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR CUP ACETABULAR CUP KWA DEPUY INTERNATIONAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention