BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COM RPSFLEX FEM CEM R STD+

    MDR report key: 2134032 · Received June 15, 2011

    Report

    Report Number
    1818910-2011-10657
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    NJL
    PMA / PMN Number
    P830055/S101
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THIS ISSUE WAS DISCUSSED BY CLINICAL, MARKETING AND PRODUCT DEVELOPMENT AS WELL A (B)(4) WAS CONDUCTED FOR THIS ISSUE AND DOCUMENTED THROUGH (B)(4). PATELLA CREPITUS IS A KNOWN PHENOMENON WHICH IS WELL DOCUMENTED IN LITERATURE AND AFFECTS ALL PS (POSTERIOR STABILIZED) KNEE DESIGNS TO SOME EXTENT FOR ALL COMPANIES THAT DESIGN AND MANUFACTURE PS KNEES. A CLINICAL LITERATURE REVIEW DATED (B)(4) 2010 SHOWS THAT ALL MANUFACTURERS EXPERIENCE THE PATELLA CREPITUS PROBLEM WITH CLINICAL RATES RANGING FROM (B)(4). THERE WAS NO CLINICAL LITERATURE AVAILABLE FOR CREPITUS ON LCS RPS; THE PATELLA CREPITUS WERE OBTAINED FROM INTERNAL COMPLAINTS SEARCH AND A RESULTING CRUDE COMPLAINTS RATE OF (B)(4). THESE COMPLAINTS CAME PREDOMINANTLY FROM (B)(4) INTERNATIONAL CENTRE/SURGEON AND (B)(4) CAME IN FROM THE US. IT IS THE OPINION OF THIS (B)(4) TEAM THAT THE INTERNAL COMPLAINTS ANALYSIS RATE OF (B)(4) FOR PATELLA CREPITUS ON LCS RPS IS IN-LINE WITH THE RATE THAT OTHER MANUFACTURERS EXPERIENCE WITH THE PATELLA CREPITUS PROBLEM AND THEREFORE THE RISK VS. BENEFIT IS STILL ACCEPTABLE. THEREFORE THIS (B)(4) TEAM CONCLUDES THAT NO FURTHER ACTION IS CURRENTLY REQUIRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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

    THE PATIENT HAD PATELLA RESURFACING. THE SURGEON NOTIFIED US IN WRITING. NO IMPLANTS WERE REMOVED. THE SURGEON STATES THE ISSUE IS PATELLA CREPIDIS AS A RESULT OF THE IMPLANT DESIGN OF THE LCS RPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COM RPSFLEX FEM CEM R STD+ 87 NJL NJL DEPUY (IRELAND) NA 2948531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention