BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG MOD TIB TRAY CEM COCR 2.5

    MDR report key: 4093534 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28211
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    March 31, 2013
    Report Date
    September 3, 2014
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    JWH
    PMA / PMN Number
    PK032151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE SUPPLIED PATIENT MEDICAL RECORDS AND PHOTOCOPIES OF RADIOGRAPHS CONFIRMED TIBIAL DEVICE LOOSENING AND OSTEOLYSIS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE DEVICE LOOSENING OR OSTEOLYSIS WITH THE INFORMATION AVAILABLE. THE RECORDS INDICATE THE PATIENT IS OBESE. THE IFU CAUTIONS THAT OBESITY TENDS TO IMPOSE SEVERE LOADING ON THE AFFECTED EXTREMITY THEREBY PLACING THE PATIENT AT HIGHER RISK OF FAILURE OF THE KNEE REPLACEMENT. IT IS NOT KNOWN TO WHAT EXTENT THIS CONTRIBUTED TO THE COMPLAINT. WITH THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE COMPLAINT IS PRODUCT RELATED. 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

    CLINICAL REPORT STATES THAT PATIENT EXPERIENCED SEVERE PAIN AND SOME SWELLING IN THE PERIPATELLAR REGION AND TIBIAL PLATEAU REGION, MEDIAL GREATER THAN LATERAL. UPDATE REC'D (B)(6) 2014 - CLINICAL REPORT STATES THAT SERIAL XRAYS INDICATE THAT THE PATIENT'S TIBIAL TRAY APPEARS TO HAVE LOOSENED AND SHIFTED SLIGHTLY OVER TIME. PATIENT WAS SENT FOR A BONE SCAN. THERE HAS BEEN NO REVISION. THERE IS NO NEW INFORMATION THAT WOULD AFFECT THE INVESTIGATION OR EXISTING MDR DECISION. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014. UPDATE REC'VD (B)(6) 2014 - CLINICAL REPORT STATES PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED. PAIN AND STIFFNESS WERE ALSO REPORTED. (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573125 SIG MOD TIB TRAY CEM COCR 2.5 KNEE TIBIAL TRAY JWH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC CD1DA4000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention