BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML LG STATURE 13.5MM

    MDR report key: 2832089 · Received November 14, 2012

    Report

    Report Number
    1818910-2012-24742
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    September 23, 2011
    Report Date
    August 17, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K012364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. (B)(4).24742.PDF]

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED PAIN IN HIS HIP, WHICH STEADILY GREW WORSE. THE PATIENT'S RIGHT LEG WAS LONGER THAN HIS LEFT. THE PATIENT LIMITED HIS PHYSICAL EXERCISE AND ACTIVITY IN AN ATTEMPT TO REDUCE THE PAIN. THE PAIN IN HIS RIGHT HIP BECAME CONSTANT, AND WAS AGGRAVATED BY WALKING, RIDING HIS BICYCLE, AND MOWING HIS LAWN. THE PATIENT HAD HIGHLY ELEVATED METAL ION LEVELS OF CHROMIUM AND COBALT. DURING THE REVISION SURGERY A SLIGHT GRAY-TINGED FLUID WAS SEEN AND SOME GRAYISH SOFT TISSUE STAINING WAS APPRECIATED IN THE TISSUE SURROUNDING THE REGION OF THE IMPLANT. POST-SURGERY, THE PATIENT SUFFERED PAIN, SORENESS, WEAKNESS, SORENESS, WAS UNABLE TO WALK LONG DISTANCES OR SIT FOR A LONG PERIOD OF TIME AND IS MORE SEDENTARY DUE TO PAIN WITH INCREASED ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML LG STATURE 13.5MM TOTAL HIP IMPLANT LPH DEPUY WARSAW X1WCJ1000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention