BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

    MDR report key: 9494236 · Received December 19, 2019

    Report

    Report Number
    3005180920-2019-01080
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    November 27, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826580
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 DECEMBER 2019. LOT 1811496: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2019. EXPIRATION DATE: 20.03.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT. 189152. BATCH REVIEW PERFORMED ON 17-DEC-2019. LOT 189152: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2019. EXPIRATION DATE: 30/01/2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2019, THE PATIENT CAME IN COMPLAINING OF PAIN AND IT WAS OBSERVED THAT THE POLY HAD BECOME DISENGAGED, NO SCREW WAS USED. THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287591 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1811496 07630030826580

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention