BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 3033468 · Received April 3, 2013

    Report

    Report Number
    1818910-2013-06470
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 28, 2013
    Report Date
    September 3, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. REF. (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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. PRE-OP NOTES INDICATE THE PATIENT NOTICED INCREASED CLICKING AND CLUNKING. ADDITIONALLY, SURGEONS X-RAY REVIEW SUGGESTED INCREASED ANTEVERSION OF THE CUP IN COMPARISON TO PREVIOUS FILMS.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES ELEVATED LEVELS OF COBALT AND CHROMIUM. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137488 ASR ACETABULAR CUPS 52 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2676688

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention