BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE POLY PATELLA STD+

    MDR report key: 1800457 · Received August 12, 2010

    Report

    Report Number
    1818910-2010-05081
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    NJL
    PMA / PMN Number
    P830055/S113
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    (B)(4) REPORTS: PATIENT PRESENTED WITH A PAINFUL AND SWOLLEN KNEE IN 2008. (B)(6) RESURFACED PATELLA ON (B)(6) 2008. PATIENT CONTINUED TO HAVE A PAINFUL AND SWOLLEN KNEE. THIS PATIENT IS PART OF THE (B)(6). THE PATIENT HAD A TOTAL KNEE REVISION (B)(6) 2010. GREY TISSUE FOUND AROUND IMPLANT. FEMUR PRESENTED WITH LONGITUDINAL SCRATCHES AND TIBIA WITH ROTATIONAL SCRATCHES. IMPLANTS REMOVED. LARGE AMOUNT OF BONE LOSS ON THE FEMUR. REVISED TO LCS VVC WITH FEMORAL METAPHYSEAL SLEEVE. EXAMINATION OF THE RETURNED PRODUCTS CONFIRMED THE REPORTED EVENT. THE INVESTIGATION CONCLUDED THE REPORTED EVENT WAS DESIGN RELATED. (B)(4) WAS CONDUCTED ON THIS REPORTED EVENT AS WELL AS ALL INFORMATION WILL BE TRACKED AND DOCUMENTED THOUGH CAPA (B)(4). 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

    PATIENT REVISED FOR PAINFUL AND SWOLLEN KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE POLY PATELLA STD+ NJL DEPUY (IRELAND) NA 2173511

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention