BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT LG 10MM

    MDR report key: 2844690 · Received November 26, 2012

    Report

    Report Number
    1818910-2012-28060
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    NJL
    PMA / PMN Number
    P830055/S113
    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.

    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 WERE CONDUCTED FOR ADDITIONAL INVESTIGATIONAL INPUTS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT; HOWEVER, INTRAOPERATIVE FINDINGS BY THE PHYSICIAN SUGGEST THAT THE PATIENTS PAIN WAS DUE TO EXCESSIVE BONE FORMATION OF THE BONE PROSTHETIC MARGINS, SPECIFICALLY THE POSTERIOR CAPSULE, AND NOT PRODUCT RELATED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE AND NO EVIDENCE SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR, 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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT LG 10MM TIBIAL INSERT NJL DEPUY RAYNHAM EE7HG4000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention