BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2936116 · Received January 30, 2013

    Report

    Report Number
    1818910-2013-01265
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 29, 2011
    Report Date
    January 22, 2013
    Manufacturer
    DEPUY INTERNATIONAL 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
    CA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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. (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 CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.(B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE ASR HIP WAS EXPLANTED DUE TO PERMANENT PHYSICAL INJURIES, PAIN, DISFIGUREMENT AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    UPDATE 1/21/16 MEDICAL RECORDS RECEIVED. CASE INFORMATION FORM AND COMPONENT STICKER SHEET REVIEWED FOR MDR REPORTABILITY. STEM AND TAPER SLEEVE ADDED FOR ALLEGED EXCESSIVE LEVELS OF CHROMIUM AND COBALT WITH NO LAB RESULTS FOR CHROMIUM AND COBALT. PART/LOT UPDATED THE COMPLAINT WAS UPDATED ON: 2/12/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41459 ASR UNI FEMORAL IMPL SIZE 46 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD - 8010379 2556722

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention ASR ACETABULAR CUPS 52| ASR TAP SLV ADAP 12/14 -1| PRODIGY LG STAT SHT LT 12.0MM