BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK PATELLOFEMORAL-R-SZ 4

    MDR report key: 5087095 · Received September 18, 2015

    Report

    Report Number
    3005985723-2015-00163
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 24, 2015
    Report Date
    August 24, 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

    THE FOLLOWING OTHER DEVICE WAS ALSO LISTED IN THIS REPORT: MCK PATELLA RESURFACING ROUND DOME-35MM; CAT# 180320-4; LOT# 12150710. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND DISEASE PROGRESSION INVOLVING A MAKO PATELLOFEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: REVIEW OF MEDICAL RECORDS WAS NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION THE COMPLAINT DATABASES AND THERE WERE NO SIMILAR REPORTED EVENTS FOR THIS LOT. CONCLUSIONS: THE EXACT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED. 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 NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    DR. (B)(6) REVISED A MAKO PF ORIGINALLY DONE ON (B)(6) 2012 TO A TRIATHLON PRIMARY TKA DUE TO PAIN AND DISEASE PROGRESSION.

    Description of Event or Problem · 1

    DR. (B)(6). REVISED A MAKO PF ORIGINALLY DONE ON (B)(6) 2012 TO A TRIATHLON PRIMARY TKA DUE TO PAIN AND DISEASE PROGRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619154 MCK PATELLOFEMORAL-R-SZ 4 KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P NPJ STRYKER ORTHOPAEDICS-MAHWAH 14900709-1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention