BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 L

    MDR report key: 7872477 · Received September 13, 2018

    Report

    Report Number
    3005180920-2018-00679
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    August 14, 2018
    Report Date
    September 13, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827150
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2018; LOT 140308: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 MAY 2014. EXPIRATION DATE: 2019-03-31; 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. OTHER DEVICES INVOLVED: FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L REFERENCE 02.12.0023L (K140826); LOT 151962: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 APRIL 2015. EXPIRATION DATE: 2020-02-29. 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. TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L REFERENCE 02.12.0312FL (K121416); LOT 134431: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 NOVEMBER 2013. EXPIRATION DATE: 2018-09-30; 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS (B)(4) ON 13 SEPTEMEBR 2018; KNEE REVISION SURGERY OCCURRED 2 YEARS AFTER CEMENTED TOTAL KNEE ARTHROPLASTY IN A HEAVY (B)(6) YEAR OLD PATIENT. ACCORDING TO THE REPORT, THE CAUSE OF REVISION IS LIGAMENT LAXITY THAT REQUIRED A MORE CONSTRAINED KNEE SYSTEM. THIS DIAGNOSIS SEEMS VERY CONVINCING GIVEN THE PREVIOUS OPERATIONS THAT THIS KNEE WAS SUBJECTED TO.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO LIGAMENTS LAXITY 2 YEARS AND 3 MONTHS AFTER PRIMARY SURGERY. GMK-SPHERE WAS REPLACED BY A GMK-HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714549 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 140308 07630030827150

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention