BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL TAP SLV ADAP 11/13+0

    MDR report key: 2821727 · Received November 6, 2012

    Report

    Report Number
    1818910-2012-24448
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    August 6, 2012
    Report Date
    May 30, 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
    NZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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. REF. (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(S) FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    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. RIGHT. ASR XL. REASON(S) FOR REVISION: UNKNOWN. UPDATE : FURTHER PRODUCT (SLEEVE) ADDED AS PER UPDATE EMAIL RECEIVED 26 OCT 2012. UPDATE - ADDED REASON FOR REVISION TAKEN FROM CLAIMSUITE DATED 23RD APRIL 2013. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE - MARKED AS LEGAL. FROM (B)(6) SPREADSHEET DATED 30TH MAY 2014. I REQUESTED PATIENT DEMOGRAPHICS FROM FILE HANDLER ON 12 JUNE 2014. HOWEVER AS PATIENTS ARE ANONYMOUS IN (B)(6) SHE WAS UNABLE TO PROVIDE THE REQUESTED DETAILS. SHE DID HOWEVER PASS ON THE CLINICAL CORRESPONDENCE WHICH INCLUDES RADIOLOGY REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR XL TAP SLV ADAP 11/13+0 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD. 8010379 1188589

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention