BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE 02.18.IF2.08.RM TIBIAL INSERT FIX S2 RM - 8MM

    MDR report key: 14374585 · Received May 12, 2022

    Report

    Report Number
    3005180920-2022-00363
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 12, 2022
    Report Date
    June 23, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895869
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 APRIL 2022. LOT 2104796: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2021. EXPIRATION DATE: 2026-JUN-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT (IN THIS EVENT, 2 DEVICES ARE REPORTED). OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 26 APRIL 2022. MOTO PARTIAL KNEE 02.18.TF2.RM TIBIAL TRAY FIX CEMENTED S2 RM (K162084) LOT 2013289: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAR-2021. EXPIRATION DATE: 2026-MAR-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE RETURNED UHMWPE INSERTS PERFORMED BY MEDACTA KNEE R&D MANAGER: THE POSTERIOR FEATURE OF THE INSERT INTENDED TO BE ENGAGED IN THE POSTERIOR DEDICATED SEAT OF THE BASEPLATE, HAS BEEN PLASTICALLY DEFORMED AND DAMAGED. IT PRESENTS A SORT OF INCISION OF THE NEGATIVE SHAPE OF THE EDGE OF THE BASEPLATE. THIS IS VISIBLE ON BOTH THE INSERTS OBJECT OF THE COMPLAINT. THE ANTERIOR ELASTIC LIP OF THE INSERTS LOOK DAMAGED AS WELL. WE CAN SUPPOSE THAT , IN THE FIRST ATTEMPT TO FIX EACH OF THE INSERT INTO THE BASEPLATE, THE INSERT WAS NOT WELL SEATED AND POSITIONED IN THE BASEPLATE. IN THESE ATTEMPTS THE INSERT WAS PUSHED DOWN AND POSTERIORLY AND WAS PERMANENTLY DAMAGED BOTH POSTERIORLY AND ANTERIORLY, COMPROMISING THE POSSIBILITY TO BE ENGAGED IN THE FOLLOWING ATTEMPTS.

    Description of Event or Problem · 0

    THE TWO INSERTS COULDN'T BE FIXED TO THE TIBIAL TRAY. THE FRONT LOCK PART OF THE 1ST AND 2ND INSERTS DEFORMED WHEN THE SURGEON TRIED TO INSERT THEM. A 3RD INSERT OF ANOTHER LOT (REF:02.18.IF2.08.RM, LOT:2115121) COULD BE FIXED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. DELAY TIME IS 30MIN AND TOTAL TIME IS 2HOURS 15MIN. FEMUR WAS ALREADY IN PLACE. THIS WAS IS THE 1ST SURGERY WITH MOTO FOR THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956301 MOTO PARTIAL KNEE 02.18.IF2.08.RM TIBIAL INSERT FIX S2 RM - 8MM KNEE TIBIAL INSERT HSX MEDACTA INTERNATIONAL SA 02.18.IF2.08.RM 2104796 07630030895869

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other