BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 49

    MDR report key: 2802837 · Received October 24, 2012

    Report

    Report Number
    1818910-2012-77054
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 13, 2011
    Report Date
    December 11, 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
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    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

    DEPUY STILL 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

    ASR REVISION; ASR XL (LEFT); REASON FOR REVISION: PAIN.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: PAIN AND INCREASED METAL ION LEVELS.

    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 (LEFT). REASON(S) FOR REVISION: PAIN AND INCREASED METAL ION LEVELS. UPDATE: ADDED FURTHER REASON FOR REVISION AND ADDED PRODUCT. RECEIVED: JANUARY 14TH 2013. UPDATE - ADDED LOT NUMBERS TO CUP AND HEAD TAKEN FROM CLAIMSUITE DATED 10TH APRIL 2013 UPDATE DATED 11TH DEC 14 - WE HAVE BEEN INFORMED BY (B)(6) THAT THIS PATIENT IS DECEASED. THE DATE OF DEATH IS UNKNOWN BUT BELIVED TO BE IN (B)(6) 2014 ADDED LOT NUMBER FOR SLEEVE, ADDITIONAL SURGEON, ADDITIONAL HOSPITAL, PATIENT NAME, SEX, DATE OF BIRTH, KID NUMBER, MARKED AS LEGAL. - UPDATE DATED 11TH DEC - KENNEDYS EMAIL. SLEEVE LOT NUM - 2712162. ADDITIONAL SURGEON - (B)(6). ADDITIONAL HOSPITAL - (B)(6). PATIENT NAME - (B)(6). PATIENT SEX - FEMALE PATIENT DOB: (B)(6) 1940. (B)(6): (B)(4). (B)(6) CONFIRM THAT THERE IS NO ALLEGATION MADE OF ANY POSSIBLE LINK BETWEEN DEATH AND THE ASR IMPLANTS 11 DEC 2014 -NO FURTHER INFORMATION IS AVAILABLE REGARDING THE DEATH OF THIS PATIENT. THIS PATIENT WAS REVISED OF THE ASR IMPLANTS PRIOR TO DEATH AND THE REVISION HAS BEEN INVESTIGATED AND REPORTED IN-LINE WITH THE ASR WI 08-07. (B)(6) HAVE CONFIRMED THAT THERE IS NO ALLEGATION OF A LINK BETWEEN THE ASR IMPLANTS AND THE DEATH OF THE PATIENT. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND EVALUATED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 49 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2410500

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention