BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT LG 10MM

    MDR report key: 1938891 · Received December 23, 2010

    Report

    Report Number
    1818910-2010-10563
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    December 10, 2010
    Report Date
    November 24, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 RETURNED PRODUCT WAS UNABLE TO CONFIRM THE REPORTED EVENT. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. A REVIEW OF THE DEVICE HISTORY REPORT DID NOT REVEAL ANY ANOMALIES REGARDING THE REPORTED EVENT AGAINST THE PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PRIMARY TOTAL KNEE REPLACEMENT ON (B)(6) 2010. PATIENT PRESENTED AT REVIEW CLINIC WITH PAIN AND SWELLING. INSERT WAS REVISED 8 WEEKS POST INITIAL SURGERY AND DISPLAYS SIGNS OF INCREASED TOP AND BACK SIDE WEAR.

    Description of Event or Problem · 1

    (B)(4) REPORTS: PRIMARY TOTAL KNEE REPLACEMENT ON (B)(6) 2010. PATIENT PRESENTED AT REVIEW CLINIC WITH PAIN AND SWELLING. INSERT WAS REVISED 8 WEEKS POST INITIAL SURGERY AND DISPLAYS SIGNS OF INCREASED TOP AND BACK SIDE WEAR. PLEASE INVESTIGATE. (THE SCRATCH MARKS IN NOTCH AREA OCCURED DURING EXCHANGE OF INSERT) FEMORAL AND TIBIAL COMPONENTS SEEMED NORMAL, FEMUR REF:(B)(4) LOT 3090643, TIBIA REF:(B)(4) LOT 3153540. NO PATIENT DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT LG 10MM 87 NJL NJL DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS NA EP6NK4000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention