BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMRS EXTENSION PIECE 100MM

    MDR report key: 5391835 · Received January 26, 2016

    Report

    Report Number
    0002249697-2016-00200
    Event Type
    Injury
    Date Received
    January 26, 2016
    Date of Event
    December 9, 2015
    Report Date
    December 9, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: GMRS EXTENSION PIECE 60MM; CAT# 6495-6-060; LOT# EDLJD. GMRS DIST FEM COMP STD L 65MM; CAT# 6495-2-030; LOT# EHEK2. MRH TIB ROT COMP XS-XL; CAT# 6481-2-100; LOT# 051349. MRHK FEMORAL BUSHING; CAT# 6481-2-110; LOT# 1201. MRH AXLE; CAT# 6481-2-120; LOT# LDG2S44. 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 NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED DUE TO HOSPITAL POLICY. 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 A DISTAL FEMORAL STEM AND TIBIAL CONSTRUCT LOOSENING INVOLVING A GMRS EXTENSION PIECE 100MM WAS REPORTED. CONCLUSION: BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION OR ALLEGATION THAT THE PRODUCT REPORTED IN THIS EVENT CONTRIBUTED TO THE EVENT. IT IS NOTED THAT IN ORDER TO REMOVE THE DISTAL FEMORAL STEM OR TIBIAL CONSTRUCT, THE REPORTED EXTENSION PIECES WOULD HAVE HAD TO BE EXPLANTED. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PATIENT'S LEFT KNEE DUE TO LUCENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PATIENT'S LEFT KNEE DUE TO LUCENCY. UPDATE RECEIVED FROM SALES REP: EVERYTHING REPORTED ON THIS PATIENT WAS REMOVED. THE STEM ON THE DISTAL FEMUR WAS LOOSE AND THE TIBIA WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48916 GMRS EXTENSION PIECE 100MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention