BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTM ASR XL FEM 47MM -7

    MDR report key: 2230005 · Received August 31, 2011

    Report

    Report Number
    1818910-2011-17000
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    May 24, 2007
    Report Date
    March 20, 2012
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LXH
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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

    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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2012; PATIENT FACT SHEET WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER RIGHT SIDE ON OR ABOUT (B)(6) 2007. SHE LATER EXPERIENCED DISCOMFORT, PAIN, AND SORENESS, AS WELL AS ELEVATED LEVELS OF COBALT AND CHROMIUM. PATIENT HAD THE RIGHT ASR HIP IMPLANT EXPLANTED ON (B)(6) 2007.

    Description of Event or Problem · 1

    PPF ALLEGES CLOSED DISLOCATION AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CTM ASR XL FEM 47MM -7 DEPUY CUSTOM FEMORAL IMPLANT LXH DEPUY INTERNATIONAL LTD - 8010379 A87AB1000

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention