BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 50

    MDR report key: 3801460 · Received May 9, 2014

    Report

    Report Number
    1818910-2014-18419
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 22, 2014
    Manufacturer
    DEPUY INTERNATIONAL 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ASR REVISION; ASR RESURFACING; LEFT; REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED: (B)(4) 2014 - ADDED PATIENT ID (INITIALS): AM, ADDED PATIENT AGE: (B)(6), ADDED PATIENT GENDER: MALE, ADDED HOSPITAL: (B)(6) HOSPITAL, (B)(6), LEFT NOTE AND ADDED (B)(4)REFERENCE NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280877 TOTAL ASR ACET IMP SIZE 50 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD - 8010379 2147428

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Required Intervention TOTAL ASR FEM IMP SIZE 45