BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO TOTAL KNEE PS TIBIAL BEARING INSERT

    MDR report key: 5271802 · Received December 7, 2015

    Report

    Report Number
    0002249697-2015-04156
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    January 1, 2010
    Report Date
    November 11, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040964
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A SCORPIO TOTAL KNEE PS TIBIAL BEARING INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED BUT AN IMAGE WAS PROVIDED. THE IMAGE SHOWS THAT THE WIRE IS MISSING AND THE LOCKING MECHANISM IS BROKEN. THE DAMAGE COULD BE DUE TO EXPLANTATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. DEVICE HISTORY REVIEW: CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOOD WORK FOR INFECTION WERE NOT PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: SCORPIO PS FEMUR WAFFLE POSTS W/LFIT; CAT# 71-4505R; LOT# K05W842. SERIES 7000 STANDARD TIBIA; CAT# 7115-0005; LOT# N6WMDA. UNKNOWN PATELLA; CAT# UNKNOWN; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS DEVICE WAS SENT TO (B)(6). 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

    IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800714 SCORPIO TOTAL KNEE PS TIBIAL BEARING INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO JWH STRYKER ORTHOPAEDICS-MAHWAH 19204401

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention