BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*STM STD,30 NK,16X11X150

    MDR report key: 2991202 · Received March 6, 2013

    Report

    Report Number
    1818910-2013-13240
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    September 20, 2011
    Report Date
    February 22, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAUDE REPORT ((B)(4)) SUBMITTED BY AN ATTORNEY STATES THAT A PATIENT HAS SEVERE PAIN FROM IMPLANT, WITH RESULTING CONTRACTURE WITH LOSS OF MOTION, SLEEP PROBLEMS, CATCHING AND CLICK, NEED FOR AMBULATORY AIDS, ELEVATED BLOOD METAL LEVEL, LOSS OF APPETITE/NAUSEA AND WEIGHT LOSS, FLUID AND NECROTIC TISSUE AND DEBRIS FOUND ON REVISION. CHRONIC PAIN IS CONTINUING ALONG WITH LIMITATION OF MOTION AND A SLIGHT REMAINING CONTRACTURE CAUSING LEG LENGTH DISCREPANCY AND SLEEP PROBLEMS DUE TO PAIN AND CONTINUED NEED FOR MEDICATION. PRIOR TO REVISION, HIP WAS NOTED ON X-RAY TO NOT BE IN NORMAL POSITION. DOI (B)(6) 2011 - DOR (B)(6) 2011 (HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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.

    Description of Event or Problem · 1

    MAUDE REPORT (B)(4) SUBMITTED BY AN ATTORNEY STATES THAT A PATIENT HAS SEVERE PAIN FROM IMPLANT, WITH RESULTING CONTRACTURE WITH LOSS OF MOTION, SLEEP PROBLEMS, CATCHING AND CLICK, NEED FOR AMBULATORY AIDS, ELEVATED BLOOD METAL LEVEL, LOSS OF APPETITE/NAUSEA AND WEIGHT LOSS, FLUID AND NECROTIC TISSUE AND DEBRIS FOUND ON REVISION. CHRONIC PAIN IS CONTINUING ALONG WITH LIMITATION OF MOTION AND A SLIGHT REMAINING CONTRACTURE CAUSING LEG LENGTH DISCREPANCY AND SLEEP PROBLEMS DUE TO PAIN AND CONTINUED NEED FOR MEDICATION. PRIOR TO REVISION, HIP WAS NOTED ON XRAY TO NOT BE IN NORMAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96266 S-ROM*STM STD,30 NK,16X11X150 FEMORAL HIP STEM JDI 9616671 DEPUY (IRELAND) 3095763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention