BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3241746 · Received July 22, 2013

    Report

    Report Number
    1818910-2013-21846
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 18, 2013
    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
    CA, US
    Reporter Occupation
    ATTORNEY

    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

    AGE/ DATE OF BIRTH: (B)(6)/ (B)(6) 1953. DATE RECEIVED BY MFR: 2/18/2016. UPDATE 2/18/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. DOI AND DOR UPDATED. STICKER SHEET FOR COMPONENTS RECEIVED. REVISION SURGICAL REPORT NOTED PATIENT WITH CLOUDY JOINT FLUID, NO METALLOSIS AND NO PSEUDOTUMORS. TAPER SLEEVE AND STEM ADDED FOR ALLEGATION OF ELEVATED METAL IONS WITHOUT LAB RESULTS. PART/LOT UPDATED. THE COMPLAINT WAS UPDATED ON: MAR 4, 2016 . BRAND NAME: ASR UNI FEMORAL IMPL SIZE 49. COMMON DEVICE NAME: FDA CODE: 87KWA. PART NUMBER: 999890249. LOT NUMBER: 2616104. (B)(5). PMA/510(K): K040627. DATE RECEIVED BY MFR: 5/1/2008. (B)(4). 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.

    Description of Event or Problem · 1

    LITIGATION RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, THE FORMATION OF METALLOSIS AND PSEUDOTUMORS WHICH HAVE DAMAGED BONE AND TISSUE SURROUNDING THE IMPLANTS. ALSO ALLEGED IS STIFFNESS, INFLAMMATION, LACK OF MOBILITY, AND CHROMIUM COBALT METAL TOXICITY.

    Description of Event or Problem · 1

    UPDATE 2/18/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. DOI AND DOR UPDATED. STICKER SHEET FOR COMPONENTS RECEIVED. REVISION SURGICAL REPORT NOTED PATIENT WITH CLOUDY JOINT FLUID, NO METALLOSIS AND NO PSEUDOTUMORS. TAPER SLEEVE AND STEM ADDED FOR ALLEGATION OF ELEVATED METAL IONS WITHOUT LAB RESULTS. PART/LOT UPDATED. THE COMPLAINT WAS UPDATED ON: MAR 4, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340227 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2616104

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other