BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 3043527 · Received April 9, 2013

    Report

    Report Number
    1818910-2013-04691
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    February 13, 2013
    Report Date
    November 17, 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

    (B)(4). 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

    ADDITIONAL NARRATIVE: 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 - LEFT HIP;REASON FOR REVISION: PAIN.

    Description of Event or Problem · 1

    ASR REVISION;ASR XL - LEFT HIP;REASON(S) FOR REVISION: ALVAL/SOFT TISSUE REACTION; 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 ASR XL - LEFT. REASON(S) FOR REVISION: PAIN. UPDATE (B)(4) RECEIVED APRIL 16TH, 2013. PATIENT ID NUMBER, ADDITIONAL REASON FOR REVISION, ONE PRODUCT ADDED REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE 31 OCT 2014 - MARKED AS LEGAL, ADDED KID NUMBER AND UPDATED DOI TO (B)(6) 2009. UPDATE - 17 NOV 2014 - LEGAL LETTER RECEIVED AND ATTACHED. ADDED PATIENT NAME, GENDER AND DOB.

    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. UPDATE FORM 73 RECEIVED APRIL 16TH, 2013. PATIENT ID NUMBER, ADDITIONAL REASON FOR REVISION, ONE PRODUCT ADDED. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE 31 OCT 2014 - MARKED AS LEGAL, ADDED (B)(6) SPREADSHEET, ADDED KID NUMBER AND UPDATED DOI TO (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144814 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2756877

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention