BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 4022297 · Received August 19, 2014

    Report

    Report Number
    1818910-2014-26097
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    August 11, 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
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. Z-1749/1816-2011.

    Description of Event or Problem · 1

    ASR REVISION REPORTED VIA SALES REP: RIGHT, REASON(S) FOR REVISION : RECALL. UPDATE REC'D (B)(4) 2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, DISCOMFORT, MALAISE, SWELLING, DAMAGE TO BONE AND TISSUE, AND ELEVATED METAL IONS. THE EXISTING MDR DECISION HAS BEEN REVERSED AND THE ACETABULAR CUP AND FEMORAL HEAD HAVE BEEN REPORTED. THE COMPLAINT WAS UPDATED ON: 08/19/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499277 ASR UNI FEMORAL IMPL SIZE 49 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2475078

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention