BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 18B-SML

    MDR report key: 2924024 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-11245
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    August 23, 2007
    Report Date
    January 14, 2013
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    MAUDE REPORT ((B)(4)) SUBMITTED BY AN ATTORNEY STATES THAT A PATIENT WAS REVISED TO ADDRESS PAIN. PATIENT CONTINUES TO HAVE PAIN AND LIMITATION OF MOTION SINCE REVISION, ALTHOUGH NO INFORMATION WAS PROVIDED REGARDING THE PRODUCT IMPLANTED IN THE PATIENT AT THE TIME OF THE REVISION SURGERY. DOI (B)(6) 2006 - DOR (B)(6) 2007 (HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. 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.

    Description of Event or Problem · 1

    MAUDE REPORT ((B)(4)) SUBMITTED BY AN ATTORNEY STATES THAT A PATIENT WAS REVISED TO ADDRESS PAIN. PATIENT CONTINUES TO HAVE PAIN AND LIMITATION OF MOTION SINCE REVISION, ALTHOUGH NO INFORMATION WAS PROVIDED REGARDING THE PRODUCT IMPLANTED IN THE PATIENT AT THE TIME OF THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29429 S-ROM*SLEEVE PRX ZTT, 18B-SML FEMORAL HIP STEM ACCESSORY LPH DEPUY (IRELAND) 1198015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention