BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG MOD TIB TRAY CEM SZ2.5

    MDR report key: 2885265 · Received December 26, 2012

    Report

    Report Number
    1818910-2012-84056
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    November 26, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC.
    Product Code
    JWH
    PMA / PMN Number
    PK952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS WERE CONDUCTED FOR ADDITIONAL INVESTIGATIONAL INPUTS. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS NON-UNION OF A PERIPROSTHETIC FRACTURE. THE LOCATION OF THE FRACTURE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIG MOD TIB TRAY CEM SZ2.5 TIBIAL KNEE PROSTHESIS JWH DEPUY ORTHOPAEDICS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention