BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 43

    MDR report key: 2851074 · Received November 29, 2012

    Report

    Report Number
    1818910-2012-25350
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    July 6, 2012
    Report Date
    July 28, 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
    BE
    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.

    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

     PRODUCT COMPLAINT # ==> PC-(B)(4) INVESTIGATION SUMMARY ==> 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA- (B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. DEVICE HISTORY LOT ==> NULL DEVICE HISTORY BATCH ==> NULL DEVICE HISTORY REVIEW ==> NULL 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 ACETABULAR SYSTEM - LEFT;REASON(S) FOR REVISION: PAIN; COMPONENT MALALIGNMENT; NOISE; ALVAL/SOFT TISSUE REACTION.

    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, SEE UPDATE. REASON(S) FOR REVISION: PAIN. REASON(S) FOR REVISION: COMPONENT MALALIGNMENT, NOISE, ALVAL/SOFT TISSUE REACTION. UPDATE : FURTHER REASONS FOR REVISION, PRIMARY SURGEON AND HOSPITAL, LOT NUMBER FOR STEM PRODUCT PAGE AS PER (B)(4) RECEIVED 23 NOV 2012. UPDATE - UPDATED HIP SIDE TAKEN FROM CLAIMSUITE DATED 1ST MAY 2013. RIGHT SIDE NOT LEFT AS PREVIOUSLY STATED. UPDATE - MARKED AS LEGAL, ADDED KID NUMBER AND ADDITIONAL HOSPITAL. TAKEN FROM (B)(6) EMAIL DATED 28TH JULY 2014.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, CLAIM LETTER ALLEGES ELEVATED METAL IONS, CRACKING NOISES OF THE PROSTHESIS, DISCOMFORT, TRAUMA, DISFIGUREMENT, EMOTIONAL DISTRESS, LOSS OF AMENITY AND INJURY. DOI: (B)(6) 2009; DOR: (B)(6) 2012; RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 43 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2553829

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention