BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD 12.5MM

    MDR report key: 3062798 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15467
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PRE-REVISION X-RAYS WERE REVIEWED FROM AN ENGINEERING PERSPECTIVE BY CPD. THERE ARE NO VISIBLE INDICATIONS OF FIXATION ISSUES. RADIODENSITIES LIKELY REPRESENTING THE CEMENT MANTLE ARE PRESENT AT THE BONE-IMPLANT INTERFACE FOR BOTH TIBIAL AND FEMORAL COMPONENTS IN BOTH X-RAYS. IN THE M-L VIEW THERE IS EVIDENCE OF POSSIBLE FEMORAL NOTCHING AT THE SUPERIOR ANTERIOR EDGE OF THE FEMORAL COMPONENT. FEMORAL NOTCHING HAS OFTEN BEEN LINKED WITH PAIN. THE TIBIAL TRAY EXHIBITS VISIBLE POSTERIOR SLOPE. THE LCS TECHNICAL MONOGRAPH RECOMMENDS 7-10° OF POSTERIOR SLOPE, BUT A FULL BONE X-RAY IS REQUIRED TO MAKE AN ACCURATE ANGLE MEASUREMENT FOR THIS CASE. IN THE A-P VIEW THERE IS SLIGHT MEDIAL AND LATERAL BONE OVERHANG BEYOND THE EDGES OF THE FEMORAL COMPONENT, MORE SO ON THE MEDIAL SIDE. THERE ARE NO APPARENT INDICATIONS OF ANY A-P COMPONENT ALIGNMENT ISSUES. ALSO, THERE IS A SCREW VISIBLE ANTERIOR TO THE TIBIAL STEM THAT WAS IMPLANTED TO POSSIBLY ADDRESS SOFT TISSUE FIXATION. THICKNESS OF THE POLY INSERT APPEARS ADEQUATE. EXPLANT WEAR PROPERTIES CANNOT BE ADDRESS SINCE PARTS WERE DISCARDED. THE INVESTIGATION CAN DRAW NO CONCLUSION 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 WAS PAIN, STIFFNESS AND DECREASED FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165753 LCS COMP RP INSERT STD 12.5MM TIBIAL INSERT NJL 1219655 DEPUY-RAYNHAM X3TBF4000

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention