BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +0

    MDR report key: 2924498 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-11265
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 14, 2013
    Report Date
    August 6, 2013
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. DATE OF IMPLANT HAS BEEN PROVIDED. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    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

    PATIENT WAS REVISED TO ADDRESS PAIN. DOI APPROX 2007 - DOR (B)(6) 2013 (RIGHT 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. FOLLOW UP WAS PERFORMED FOR ADDITIONAL INVESTIGATIVE IN-PUTS BUT NO ADDITIONAL INFORMATION WAS OBTAINED. 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

    **UPDATE: (B)(4) 2013 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM ELEVATED LEVELS OF COBALT AND CHROMIUM. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31312 S-ROM M HEAD 36MM +0 FEMORAL HEAD JDI DEPUY INTL., LTD. 1823078

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention