BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK SPHERE TIBIAL INSERT

    MDR report key: 7734713 · Received July 31, 2018

    Report

    Report Number
    3005180920-2018-00586
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    July 10, 2018
    Report Date
    September 26, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826146
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE UHMWPE INSERT: ON AUGUST 29, 2018 BY R&D PRODUCT MANAGER. THE MEDIAL SIDE OF THE POSTERIOR BOTTOM SURFACE OF THE INSERT PRESENTS SOME DENTS AND SCRATCHES. THE POSTERIOR "SNAPPING" FEATURES OF THE INSERT HAVE BEEN PLASTICALLY DEFORMED AND DAMAGED IN THE MEDIAL SIDE. IT PRESENTS A SORT OF INCISION WITH THE NEGATIVE SHAPE OF THE CLIPPING "TOOTH" OF THE BASEPLATE. WE CAN SUPPOSE THAT PROBABLY, IN THE FIRST ATTEMPT TO FIX THE INSERT INTO THE BASEPLATE, THE INSERT WAS NOT POSTERIORLY WELL POSITIONED. IN THIS ATTEMPT THE INSERT WAS PUSHED POSTERIORLY AND WAS PERMANENTLY DAMAGED WITHOUT POSSIBILITY TO BE CLIPPED IN THE FOLLOWING ATTEMPTS. WE CAN STATE THAT THE EVENT IS NOT IMPLANT RELATED. SOME SCRATCHES CAN BE IDENTIFIED ON THE ANTERIOR SURFACE OF THE INSERT AS WELL, MOST LIKELY CAUSED DURING THE ATTEMPT TO FORCE THE COMPONENT INTO THE BASEPLATE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 JULY 2018: LOT 180423: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 APRIL 2018. EXPIRATION DATE: 2023-04-04. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BATCH REVIEW FOR GMK TIBIAL TRAY FIXED CEMENTED # 2 R REF (B)(4) LOT. 180246 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 MAY 2018. EXPIRATION DATE: 2023-05-06. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE SURGEON WAS NOT ABLE TO INSERT THE INLAY SIZE 10MM INTO THE TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE TIBIAL INSERT SIZE 11MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576807 GMK SPHERE TIBIAL INSERT UHMWPE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 180423 07630030826146

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other