BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK PATELLOFEMORAL-L-SZ 4

    MDR report key: 5271165 · Received December 7, 2015

    Report

    Report Number
    3005985723-2015-00289
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    November 11, 2015
    Report Date
    November 11, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A MCK PATELLOFEMORAL L SZ 4 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION WERE NOT PERFORMED AS THE ITEM WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS MEDICAL RECORDS WERE NOT PROVIDED. -DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE AND MEDICAL RECORDS WERE NOT MADE AVAILABLE TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT HAD A PF MAKO IN 2012 AND HAD PAIN IN THE KNEE. THE PATIENT WAS REVISED.

    Description of Event or Problem · 1

    PATIENT HAD A PF MAKO IN 2012 AND HAD PAIN IN THE KNEE. THE PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801996 MCK PATELLOFEMORAL-L-SZ 4 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ STRYKER ORTHOPAEDICS-MAHWAH 26330711-02

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention