BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMA HI OFFSET L SZ 4

    MDR report key: 3822366 · Received May 20, 2014

    Report

    Report Number
    1818910-2014-19177
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 20, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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

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

    Description of Event or Problem · 1

    ASR REVISION. RIGHT ASR XL. REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED: 20TH MAY 2014 - ADDED DCGI REFERENCE NUMBER, ADDED PATIENT INITIALS, ADDED SURGEON TITLE, AMENDED IMPLANT DATE: (B)(6) 2007, ADDED HOSPITAL AREA: (B)(6), ADDED FURTHER HOSPITAL: (B)(6), ADDED PATIENT AGE, ADDED PATIENT GENDER AND ADDED FURTHER REASON(S) FOR REVISION: DIFFICULTY WALKING.

    Description of Event or Problem · 1

    ASR REVISION, RIGHT, ASR XL, REASON(S) FOR REVISION: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298410 PROXIMA HI OFFSET L SZ 4 HIP FEMORAL STEM/SLEEVE KWZ DEPUY INTERNATIONAL LTD - 8010379 2203110

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention