BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L

    MDR report key: 7486985 · Received May 4, 2018

    Report

    Report Number
    3005180920-2018-00295
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    April 5, 2018
    Report Date
    June 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862618
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE EXPLANTED INSERT FIXATION SCREW ON 23 MAY 2018 BY R&D PRODUCT MANAGER: LOOSENED INSERT SAFETY SCREW OCCURRED ABOUT 2 YEAR AND 8 MONTHS AFTER PRIMARY SURGERY REMOVED BY ARTHROSCOPY. THE HEAD AND THE THREADED PART OF THE SCREW LOOKS COMPLETELY DAMAGED AND PLASTICALLY DEFORMED. THREADS HAVE BEEN PRESSED ONCE, BACKED OUT FROM THE BASEPLATE, WERE INTERPOSED BETWEEN THE FEMORAL COMPONENT AND THE TIBIA INSERT AND UNDERWENT TO THE BODY LOAD. NO OTHER COMPONENTS HAVE BEEN REMOVED, SO WE CAN SUPPOSE THAT THEY HAVE BEEN FOUND IN GOOD CONDITION DURING ARTHOSCOPY TO REMOVE THE SCREW. THE MOST-LIKELY CAUSE FOR SELF-UNSCREWING OF THE SCREW AFTER FEW MONTHS FROM IMPLANTATION, WAS INSUFFICIENT TIGHTENING TORQUE. USING A SCREWDRIVER PROVIDED WITH A TORQUE LIMITATION (REF. 02.07.10.4577; TORQUE LIMITER SCREWDRIVER 3.5 NM) WOULD PREVENT THIS EVENT. TORQUE LIMITER SCREWDRIVER IS ALREADY AVAILABLE AND ITS USE IS MANDATORY. NO FURTHER CONSIDERATIONS CAN BE DONE BASING ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 MAY 2018. LOT 143217: 50 ITEMS MANUFACTURED AND RELEASED ON 26 SEPTEMBER 2014 EXPIRATION DATE: 2019-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 29 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 3 YEARS AFTER PRIMARY THE TIBIAL INLAY SCREW COME OUT. THE SURGEON REMOVED IT ARTHROSCOPICALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329229 TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 143217 07630030862618

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention