BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 3191773 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-19966
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    April 15, 2013
    Report Date
    June 15, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL - LEFT, REASON(S) FOR REVISION: UNKNOWN. FORM RECV'D: (B)(4) 2013. REASON(S) FOR REVISION ADDED. ALVAL / SOFT TISSUE REACTION. MRI FINDINGS CONSISTENT WITH A SUBTLE PROGRESSION OF AN ADVERSE REACTION TO METAL DEBRIS. INTERVAL INCREASE IN METAL ION LEVELS. STEM ADDED. (B)(6). BILATERAL: SEE COM (B)(4) FOR RIGHT HIP REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290474 TOTAL ASR ACET IMP SIZE 54 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2451953

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention