BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM*NRH REPL HINGE PIN/MEDIUM

    MDR report key: 3110556 · Received May 14, 2013

    Report

    Report Number
    1818910-2013-17000
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 31, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    JWH
    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

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A LOT SPECIFIC SEARCH OF THE COMPLAINTS DATABASES WAS NOT POSSIBLE AS THE NECESSARY PRODUCT/LOT CODE COMBINATION WAS NOT PROVIDED. IT SHOULD BE NOTED, THE ORIGINAL REPORTING STATED THE PIN WAS NOT PROPERLY PLACED AND DID NOT ACHIEVE A SECURE LOCK. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD 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.

    Description of Event or Problem · 1

    REASON FOR REVISION: THE HINGE PIN HAD NOT BEEN PUT IN PROPERLY AND WAS NOT CLICKED IN TO PLACE.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2013 DOI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213036 SROM*NRH REPL HINGE PIN/MEDIUM HINGE PIN JWH DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention