BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2961512 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-01334
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    March 22, 2011
    Report Date
    February 5, 2013
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND CUP LOOSENING. THE BACKSIDE OF THE DEVICE WAS FULL OF SOFT TISSUE. UPDATE LITIGATION ALLEGED THE ASR HIP WAS EXPLANTED DUE TO PAIN, WEAKNESS, DIFFICULTY WITH DAILY LIVING ACTIVITIES AND INCREASED METALLIC IONS IN HER BLOODSTREAM. THERE IS NO NEW INFORMATION THAT CHANGES THE OUTCOME OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND CUP LOOSENING. THE BACKSIDE OF THE DEVICE WAS FULL OF SOFT TISSUE. UPDATE (B)(6) 2013 LITIGATION ALLEGED THE ASR HIP WAS EXPLANTED DUE TO PAIN, WEAKNESS, DIFFICULTY WITH DAILY LIVING ACTIVITIES AND INCREASED METALLIC IONS IN HER BLOODSTREAM. THERE IS NO NEW INFORMATION THAT CHANGES THE OUTCOME OF THIS INVESTIGATION. **UPDATE**(B)(6) 2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FOR THE FEMORAL HEAD. 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
    64858 ASR UNI FEMORAL IMPL SIZE 45 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2448459

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention