BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 62

    MDR report key: 3150973 · Received June 6, 2013

    Report

    Report Number
    1818910-2013-18340
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 16, 2013
    Report Date
    January 20, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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

    UPDATE REC¿D (B)(4) 2014 - LEGAL CLAIM WAS RECEIVED, WHICH IDENTIFIED DOI INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN,METALLIC DEBRIS, AND SCAR TISSUE. ALSO FOR HIGH LEVELS OF COBALT AND CHROMIUM LEVELS, AND OSTEOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249884 ASR ACETABULAR CUPS 62 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2141312

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention