BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGN PRSFT STEM 10MMX220MM STRT

    MDR report key: 6962078 · Received October 19, 2017

    Report

    Report Number
    1020279-2017-00889
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    October 9, 2017
    Report Date
    May 2, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    UDI-DI
    03596010546869
    PMA / PMN Number
    K072531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510KS OF ASSOCIATED CONCOMITANT DEVICES: K081111, K043440.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICES WERE RETURNED. THE DAMAGE OBSERVED ON THE PRESS FIT STEM IS CONSISTENT WITH IMPLANT EXTRACTION DAMAGE. THE FRACTURED ENDS HAVE BEEN BURNISHED TO A SMOOTH SURFACE. THIS WAS LIKELY CAUSED BY THE FRACTURED ENDS OF THE STEM RUBBING PRIOR TO EXTRACTION. DAMAGE SEEN ON THE CEMENT STEM, ON THE TIBIAL BASEPLATE¿S POLISHED AND ANTERIOR SURFACES, AND ON THE POST BUSHING COULD HAVE BEEN CAUSED DURING REMOVAL. WEAR SEEN ON THE ARTICULAR SURFACE OF THE FEMORAL ASSEMBLY MAY HAVE BEEN CAUSED BY THIRD BODY DEBRIS OR DURING REMOVAL. WEAR SEEN ON THE HINGE SLEEVE WAS LIKELY CAUSED BY NORMAL USE. THE AMOUNT OF CEMENT SEEN ON THE FIXATION SURFACE INDICATES THAT THERE MAY COMPROMISED BONE STOCK. DAMAGE OBSERVED ON THE ARTICULAR SURFACE OF THE TIBIAL INSERT MAY HAVE BEEN CAUSED BY THIRD-BODY PARTICULATE OR DURING THE REMOVAL. THE IMPLANT WAS RECEIVED WITH THE FEMORAL ASSEMBLY ATTACHED TO THE TIBIAL BASEPLATE. THE TIBIAL BASEPLATE SET SCREWS HAVE BEEN CEMENTED IN PLACE AND CAN BE FELT INSIDE OF THE FEMALE TAPER. NO DEVIATIONS WERE OBSERVED DURING THE LAB ANALYSIS. THE BATCH NUMBER OF THE FRACTURED PRESS FIT STEM IS UNKNOWN. WITHOUT THE REQUESTED MEDICAL IMAGES, THE ROOT CAUSE CANNOT BE CONCLUDED. THE PATIENT¿S WEIGHT, THE KNOWN DISTAL DEFECTS, AND THIN FEMORAL CONDYLES TOGETHER WITH A WELL FIXED PROXIMAL FEMORAL STEM MIGHT HAVE CONTRIBUTED TO FRACTURE. THE NOTED QUANTITY OF BONE CEMENT OF THE FEMORAL COMPONENT INDICATES THAT IT IS LIKELY THAT THERE WAS LESS STABILITY OF THE COMPONENT, WHICH COULD LEAD TO MICRO MOTION AND STRESS ON THE STEM. WEAR TO THE FRACTURE SURFACES OF THE STEM DOCUMENTED IN THE LAB ANALYSIS PROHIBITED THE FATIGUE STRESS ASSESSMENT. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED A RIGHT KNEE REVISION SURGERY WAS PERFORMED DUE TO A FRACTURED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740033 LGN PRSFT STEM 10MMX220MM STRT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH SMITH & NEPHEW, INC. 03596010546869

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R