BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPER SLEEVE ADAPTER 12/14 +8

    MDR report key: 4131013 · Received October 1, 2014

    Report

    Report Number
    1818910-2014-29166
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 19, 2014
    Report Date
    March 13, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD.-8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    ADDITIONAL NARRATIVE: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 XL, LEFT, REASON(S) FOR REVISION : PAIN. UPDATE - RECEIVED CONFIRMATION THAT REVISION HAS TAKEN PLACE. TAKEN FROM (B)(6) SPREADSHEET DATED 12TH SEPT 2014. UPDATE: UPDATED REVISION DATE TO 21 AUG 2014, UPDATED HOSPITAL DETAILS AND PRODUCT EXPIRY DATES, ADDED STEM DETAILS. TAKEN FROM (B)(6) EMAIL 12 MARCH 2015 (PD 13 MARCH 2015).

    Description of Event or Problem · 1

    ASR REVISION.ASR XL.LEFT.REASON(S) FOR REVISION : PAIN.UPDATE - RECEIVED CONFIRMATION THAT REVISION HAS TAKEN PLACE. TAKEN FROM (B)(6) SPREADSHEET DATED (B)(6) 2014

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613038 TAPER SLEEVE ADAPTER 12/14 +8 HIP OTHER IMPLANT KWA DEPUY INTERNATIONAL LTD.-8010379 1812847

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention