BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE MOD HEAD ADAPT 12/14 +5

    MDR report key: 1962324 · Received January 7, 2011

    Report

    Report Number
    1818910-2010-10697
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 18, 2010
    Report Date
    August 21, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. (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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THIS IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER SINCE IT IS ONLY INDICATED TO BE USED AS A HEMI IN THE US AT THIS TIME. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    REVISED FOR ALVAL.

    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 - (B)(4). ASR REVISION - RIGHT HIP. ORIGINALLY REPORTED (B)(6) 2010, EVENT (B)(6) 2010. PAIN AND INABILITY TO FLEX HIP. REVISION OF ASR XL HEAD/CUP TO PINNACLE COC. CORAIL STEM REMAINED IN PLACE. (B)(6) - UPDATE FROM (B)(6) SPREADSHEET DATED (B)(6) 2011- CHANGED REVISION REASON AND REVISION DATE. UPDATE - ADDED A STEM, HOSPITAL, AND ADDITIONAL REASON FOR REVISION. TAKEN FROM CLAIMSUITE DATED (B)(6) 2014.

    Description of Event or Problem · 1

    ASR REVISION - RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE MOD HEAD ADAPT 12/14 +5 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2008983

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention