BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 3071026 · Received April 22, 2013

    Report

    Report Number
    1818910-2013-05063
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    July 20, 2010
    Report Date
    January 18, 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
    US
    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

    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

    ASR REVISION; ASR XL - RIGHT HIP; REASON FOR REVISION: 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 - RIGHT. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE RECEIVED: 18TH JANUARY 2014 - AMENDED REVISION DATE: (B)(6) 2007 AND CROSS REFERENCED. BI-LATERAL PATIENT - SEE (B)(4) FOR LEFT SIDE REVISION. SURGEON CONFIRMATION FORM RECEIVED 16TH JUNE 2014. REVISION DATE AND SURGERY DATE AMENDED. ADDITIONAL REASON FOR REVISION ADDED. MANUFACTURING DATES ADDED. COMMON NAME AND CONSTRUCT TYPE AMENDED FOR TAPER SLEEVE. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION, COMPONENT LOOSENING, INCORRECT SEE BELOW. UPDATE / QUERY RESPONSE RECEIVED 19TH JUNE 2014. THE POST-OP NOTES CONFIRM THAT 'NEITHER COMPONENTS LOOSE, OSTEOLYSIS. FLORID METAL ON METAL REACTION, WITH CASEOUS APPEARANCE AND FLUID'. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION, OSTEOLYSIS, FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173042 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2140584

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention