BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 62

    MDR report key: 2009865 · Received March 2, 2011

    Report

    Report Number
    1818910-2011-02708
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    November 4, 2004
    Report Date
    June 12, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    IN FOLLOW UP PRODUCT AND LOT CODES WERE PROVIDED. THE REPORTED PRODUCT IS PART OF AN (B)(4) STUDY AND IS NOT REPORTABLE UNDER THE FDA REPORTING GUIDELINES. DEPUY 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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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

    THE PT HAS HAD AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNK.

    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 HIP RESURFACING SYSTEM & ASR XL ACETABULAR SYSTEM. REASON(S) FOR REVISION : PAIN (1ST REV) & COMPONENT LOOSENING (2ND REV). UPDATE: HOSPITAL, SURGEON, PRODUCTS AND REVISION DETAILS ADDED AS PER EMAIL RECEIVED FROM CRAWFORDS - (B)(6) 06 JAN 2012. ORIGINAL SURGERY (B)(6) 2004 - RESURFACING SYSTEM IMPLANTED. REVISION (B)(6) 2004 - FEMORAL HEAD REMOVED, CUP LEFT IN SITU AND XL SYSTEM IMPLANTED. 2ND REVISION (B)(6) 2008 - REMOVAL OF ACETABULAR CUP AND OGEE CUP IMPLANTED. SEE FURTHER (B)(4) FOR 3RD REVISION (B)(6) 2008 REMOVAL OF XL HEAD, SLEEVE AND OGEE CUP, IMPLANT ZIMMER PRODUCTS. 19 MAY 2015 - UPDATE - ADDED RESURFACE TO ETQ - PATIENT HAS UNDERGONE THREE REVISIONS - ASR RESURFACE TO ASR XL (CUP REMAINED IN SITU) TO REMOVAL OF ASR CUP (HEAD, SLEEVE AND STEM REMAINED IN SITU) TO REMOVAL OF THE REMAINDER OF XL (HEAD AND SLEEVE - CORAIL STEM REMAINED IN SITU) (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 62 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 NA 1117669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention