BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 2792705 · Received October 16, 2012

    Report

    Report Number
    1818910-2012-76953
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    October 22, 2012
    Report Date
    March 20, 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
    US
    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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4) REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION RECOMMENDED (B)(6) 2012 RIGHT ASR XL REASON(S) FOR REVISION: PAIN UPDATE: AMENDED HOSPITAL NAME AND REVISION DATE. RECEIVED: OCTOBER 16TH 2012. REVISION DATE HAS NOW BEEN AMENDED TO (B)(6) 2012. UPDATE - ADDED REVISION DATE AND STEM . TAKEN FROM CLAIMSUITE DATED 20TH MARCH 2015 DATE OF REVISION: (B)(6) 2012 UPDATE DEC 1, 2017: EMAIL NOTIFICATION FROM (B)(4) RECEIVED. UPDATED COMPLAINANT ADDRESS. THIS COMPLAINT WAS UPDATED ON: DEC4, 2017 THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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.

    Description of Event or Problem · 1

    ASR REVISION; RIGHT ASR XL; REASON FOR REVISION: PAIN.

    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 RECOMMENDED (B)(6) 2012, RIGHT, ASR XL, REASON(S) FOR REVISION: PAIN. UPDATE: AMENDED HOSPITAL NAME AND REVISION DATE. RECEIVED: OCTOBER 16TH 2012. REVISION DATE HAS NOW BEEN AMENDED TO (B)(6) 2012. UPDATE - ADDED REVISION DATE AND STEM . TAKEN FROM CLAIMSUITE DATED 20TH MARCH 2015 DATE OF REVISION: (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2539352

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention