BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG MOD TIB TRAY CEM COCR 5

    MDR report key: 2922458 · Received January 18, 2013

    Report

    Report Number
    1818910-2013-11172
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    DEPUY IRELAND ¿ REG. # 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK032151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT BASED ON THE AVAILABLE INFORMATION. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UPDATE 6/13/2013- MEDICAL RECORDS AND PATIENT X-RAYS RECEIVED. REVIEW OF THE SUPPLIED MEDICAL RECORDS AND PATIENT X-RAYS DID NOT ADD VALUE TO CONFIRMATION OF THE REPORTED EVENT OR DETERMINATION OF ROOT CAUSE. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN NEAR THE TIBIAL TRAY. TIBIAL TRAY WAS SUSPECTED TO BE LOOSE, BUT WAS NOT FOUND TO BE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27087 SIG MOD TIB TRAY CEM COCR 5 TIBIAL KNEE PROSTHESIS JWH DEPUY IRELAND ¿ REG. # 9616671 3364388

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention