BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 11812210 · Received May 12, 2021

    Report

    Report Number
    3005180920-2021-00372
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 12, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 APRIL 2021: LOT 1901605: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUN-2019. EXPIRATION DATE: 2024-06-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. VISUAL INSPECTION OF THE RETURNED COMPONENT REVEALED THE PRESENCE OF RESIDUAL CEMENT IN THE EDGE BETWEEN THE DISTAL SURFACE OF THE BASEPLATE AND THE KEEL. NO OTHER ELEMENTS RELEVANT FOR THE EVENT CAN BE IDENTIFIED. THE RETURNED DEVICE HAS BEEN DIMENSIONALLY CONTROLLED; ITS DIMENSIONS IN TERMS OF: THICKNESS OF THE WINGS. ANGLE BETWEEN THE WINGS . SHAPE OF THE WINGS. ARE IN COMPLIANCE WITH THE SPECIFICATIONS REQUIRED. REASONS FOR THIS UNLIKELY EVENT REMAIN UNKNOWN. LOOKING AT THE BASEPLATE, WE CON ONLY HYPNOTIZE THAT DURING THE FIRST ATTEMPT THE BONE WAS NOT PROPERLY PREPARED; INDEED, IN THE SECOND ATTEMPT, THERE WAS SOME RESIDUAL CEMENT (THAT WE CAN SEE TODAY ON THE BASEPLATE) ALREADY SOLIDIFY THAT IMPEDED THE BASEPLATE TO SIT PROPERLY INTO THE PREPARED BONE; THIS REMAINS ONLY A SUPPOSITION THAT IS NOT POSSIBLE TO BE CONFIRMED. FROM VISUAL INSPECTION THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 1

    DURING THE SURGERY THE SURGEON DECIDED TO UPSIZE TIBIA TO SIZE 5. ALL THE STANDARD PREPARATION WAS SURGICALLY PERFORMED. WHEN CEMENTING THE TIBIA TRAY WOULD NOT SIT IN. CEMENT REMOVED AND PREPARATION DONE AGAIN, STILL DID NOT SIT. ANOTHER SIZE 5 TRAY WAS OPENED AND USED. SEATED AND CEMENTED WITHOUT ANY ISSUES. THERE WAS A DELAY OF HALF AN HOUR DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712108 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1205R 1901605 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other