BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE MOD HEAD ADAPT 12/14 +5

    MDR report key: 4230077 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31261
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    January 18, 2011
    Report Date
    October 28, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWY
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION, ASR XL ACETABULAR SYSTEM - LEFT, REASON(S) FOR REVISION: PAIN. UPDATE: FURTHER CLAIMSUITE RECEIVED ON (B)(6) 2014. THIS COM IS TO BE CLOSED TO CAPA DUE TO THE REASONS FOR REVISION FALLING WITHIN THE CAPA REMIT AND OFF LABEL USE OF A COMPETITOR STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715900 LARGE MOD HEAD ADAPT 12/14 +5 HIP OTHER IMPLANT KWY DEPUY INTERNATIONAL LTD. 8010379 2488938

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention