BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 43

    MDR report key: 2950449 · Received February 8, 2013

    Report

    Report Number
    1818910-2013-01939
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    March 23, 2011
    Report Date
    November 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
    SZ
    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. (B)(4). DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    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.

    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, LEFT, ASR XL, REASON(S) FOR REVISION: NOISE. UPDATE - ADDED A STEM TAKEN FROM CLAIMSUITE DATED (B)(6) 2013. UPDATE - ADDED ADDITIONAL REASONS FOR REVISION AND FILED OUT MW FIELDS. TAKEN FROM CLAIMSUITE DATED (B)(6) 2014. REASON(S) FOR REVISION: PAIN; ALVAL / SOFT TISSUE. UPDATE REC'D (B)(6) 2014 - REC'D FULL NAME OF HOSPITAL - (B)(6), EXPIRY DATES FOR ALL PRODUCTS.

    Description of Event or Problem · 1

    (B)(4). ASR REVISION.LEFT.ASR XL.REASON(S) FOR REVISION: NOISE.UPDATE - ADDED A STEM TAKEN FROM CLAIMSUITE DATED 19TH SEPTEMBER 2013.UPDATE - ADDED ADDITONAL REASONS FOR REVISION AND FILED OUT MW FIELDS. TAKEN FROM CLAIMSUITE DATED 16TH SEPTEMBER 2014.REASON(S) FOR REVISION: PAIN; ALVAL / SOFT TISSUE.

    Description of Event or Problem · 1

    ASR REVISION;ASR XL - LEFT HIP;REASON FOR REVISION: NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54430 DEPUY ASR XL FEM IMP SIZE 43 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 1232640

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention