BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX 3/10 MM RIGHT

    MDR report key: 5460394 · Received February 25, 2016

    Report

    Report Number
    3005180920-2016-00059
    Event Type
    Malfunction
    Date Received
    February 25, 2016
    Date of Event
    January 26, 2016
    Report Date
    April 29, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04 APRIL 2016 THE (B)(4) PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE EXPLANTED TIBIAL INSERT AND COMMENTED AS FOLLOWS: THE ANTERIOR AND POSTERIOR LIPS OF THE CLIPPING CONNECTION OF THE INSERT WITH THE TIBIAL BASEPLATE WERE FOUND INTACT AND WELL-PRESERVED, ALTHOUGH THE UNSUCCESSFULLY INTRA-OPERATIVE TEMPTS TO FIX THE INSERT INTO THE BASEPLATE. THE EXPLANTED INSERT WAS SUCCESSFULLY CONNECTED WITH A TIBIAL BASEPLATE SIZE 3 PRESENT IN MEDACTA'S STOCK. THIS FURTHER FUNCTIONAL TEST HAD BEEN CONDUCTED IN ORDER TO DEMONSTRATE THAT THE INSERT DIDN'T PRESENT ANY DIMENSIONAL NON-CONFORMITIES. FROM VISUAL INSPECTION IS NOT POSSIBLE TO SUPPOSE ANY POSSIBLE ROOT CAUSE OF THE EVENT. ON 25 APRIL 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 28 APRIL 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 FEBRUARY 2016. LOT 144276: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPTEMBER 2014. EXPIRATION DATE: 2019-08-31. 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. GMK TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT, CODE 02.07.1203R, LOT. 147390 S (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 MARCH 2015. EXPIRATION DATE: 2020-01-31. 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. NOT YET RECEIVED.

    Description of Event or Problem · 1

    DURING SURGERY THE 10MM INSERT WOULD NOT LOCK INTO THE TIBIAL BASEPLATE. THE SALES AGENT HAD AN EXTRA INSERT THAT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THE SALES AGENT DID NOT NOTICE ANYTHING WRONG WITH THE INSERT BUT IT WILL BE RETURNED TO MEDACTA INTERNATIONAL SA FOR ANALYSIS. THE INSERT WILL BE RETURNED. THERE ARE NO X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116536 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX 3/10 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 144276

    Patients

    Seq Age Sex Outcome Treatment
    1 Other