BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED ASR CUP OR HEAD

    MDR report key: 4770076 · Received May 13, 2015

    Report

    Report Number
    1818910-2015-20693
    Event Type
    Injury
    Date Received
    May 13, 2015
    Date of Event
    May 6, 2015
    Report Date
    December 16, 2015
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE.

    Description of Event or Problem · 1

    ASR REVISION; ASR RESURFACING - HIP SIDE LEFT; REASONS FOR REVISION: UNKNOWN; DOI: UNKNOWN. UPDATE (B)(4) 2015: UPDATE HIP SIDE AS LEFT. ((B)(4))

    Description of Event or Problem · 1

    UPDATE 1 DEC. 2015: UPDATING DOI AND DOR AS REVISION HAS NOT TAKEN PLACE. TAKEN FROM KENNEDY'S SPREADSHEET 16 NOV. 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313700 UNIDENTIFIED ASR CUP OR HEAD HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R