BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2890846 · Received December 31, 2012

    Report

    Report Number
    1818910-2012-26047
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    September 1, 2007
    Report Date
    June 6, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 181891092013-00508. THIS REPORT, 1818910-2012-26047 WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 181891092013-00508. DEPUY STILL 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

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED SEVERE PAIN, MULTIPLE DISLOCATIONS OF THE HIP, TROUBLE SLEEPING AND WALKING, AND OTHER INJURIES FROM EXCESSIVE LEVELS OF CHROMIUM AND COBALT WITHIN THE IMPLANTED ASR HIP. **UPDATE** (B)(4) 2013 - PPD RECEIVED (B)(4) 2012 IDENTIFYING PART AND LOT NUMBERS. **UPDATE** (B)(4) 2013 - MEDICAL RECORDS RECEIVED (B)(4) 2013. THE RECORDS INDICATE THAT PATIENT HAD AN INFECTED, DISLOCATED, LEFT HEMIARTHROPLASTY IN (B)(6) 2007 AND ANTIBIOTICS WERE PLACED AT THAT TIME. DATE OF REVISION IS UNKNOWN.

    Description of Event or Problem · 1

    LITIGATION ALLEGED, THE PATIENT SUFFERED SEVERE PAIN, MULTIPLE DISLOCATIONS OF THE HIP, TROUBLE SLEEPING AND WALKING, AND OTHER INJURIES FROM EXCESSIVE LEVELS OF CHROMIUM AND COBALT WITHIN THE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2168128

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention