BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2213434 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-15116
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    April 3, 2013
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, DEVICE PRODUCT CODE, CATALOG #/LOT #, PMA/510(K) #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    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.

    Description of Event or Problem · 1

    COMMENT: MEDICAL RECORDS INDICATE A CORRECTION TO DOI/DOR DATES. DOI: (B)(6) 2008 - DOR: (B)(6) 2012 (LEFT HIP). DOI: (B)(6) 2008 - DOR: NONE REPORTED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: BILATERAL PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER LEFT SIDE ON OR ABOUT (B)(6) 2008 AND ON HER RIGHT SIDE ON OR ABOUT (B)(6) 2008. PATIENT LATER EXPERIENCED PAIN AND ELEVATED LEVELS OF COBALT AND CHROMIUM. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF EITHER OF HER ASR HIP IMPLANTS. UPDATE: (B)(4) 2012 - THE SALES REP HAS REPORTED THE REVISION FOR THE LEFT SIDE. PATIENT WAS REVISED DUE TO PAIN AND ELEVATED METAL ION LEVELS. UPDATE: (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FOR THE RIGHT SIDE. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: BILATERAL PT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER LEFT SIDE ON OR ABOUT (B)(6), 2008 AND ON HER RIGHT SIDE ON OR ABOUT (B)(6), 2008. PT LATER EXPERIENCED PAIN AND ELEVATED LEVELS OF COBALT AND CHROMIUM. PT HAS NOT YET SCHEDULED AN EXPLANTATION OF EITHER OF HER ASR HIP IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 58 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2610297

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention