BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +5

    MDR report key: 2261261 · Received September 23, 2011

    Report

    Report Number
    1818910-2011-18212
    Event Type
    Injury
    Date Received
    September 23, 2011
    Report Date
    August 26, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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

    CORRECTED: EVENT/PROBLEM DESCRIPTION, EXPLANT DATE, DATE RECEIVED BY MANUFACTURER. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    CALL CENTER PATIENT REPORTS THAT SINCE HER LEFT HIP REPLACEMENT SURGERY, SHE CANNOT SLEEP ON THAT SIDE. PATIENT IS UNHAPPY WITH REPLACEMENT. THE PATIENT REPORTS FURTHER THAT THE CALF OF HER LEFT LEG IS ABOUT 3 INCHES THICKER THAN ON THE RIGHT. UPDATE: (B)(6) 2011 -LITIGATION PAPERS RECEIVED. REPORTS SEVERE PAIN. COMPLAINT WAS REOPENED TO MAKE COMPONENTS REPORTABLE.

    Description of Event or Problem · 1

    CALL CENTER PATIENT REPORTS THAT SINCE HER LEFT HIP REPLACEMENT SURGERY, SHE CANNOT SLEEP ON THAT SIDE. PATIENT IS UNHAPPY WITH REPLACEMENT. THE PATIENT REPORTS FURTHER THAT THE CALF OF HER LEFT LEG IS ABOUT 3 INCHES THICKER THAN ON THE RIGHT. UPDATE: (B)(4) 2011 - LITIGATION PAPERS RECEIVED. REPORTS SEVERE PAIN. COMPLAINT WAS REOPENED TO MAKE COMPONENTS REPORTABLE. UPDATE: (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DATE OF REVISION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTER SLEEVES 12/14 +5 ADAPTER SLEEVE KWA DEPUY INTERNATIONAL 2353487

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention