BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 9423946 · Received December 6, 2019

    Report

    Report Number
    3005180920-2019-01035
    Event Type
    Injury
    Date Received
    December 6, 2019
    Date of Event
    November 27, 2019
    Report Date
    December 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 NOVEMBER 2019: LOT 181946: 94 ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2018. EXPIRATION DATE: 2023-07-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 92 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT (CONSIDERING MOBILIZATION AND INFECTION). ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0006R FEMORAL COMPONENT SPHERE CEMENTED. SIZE 6 R (K121416) LOT. 183495. BATCH REVIEW PERFORMED ON 28 NOVEMBER 2019: LOT 183495: 35 ITEMS MANUFACTURED AND RELEASED ON 05-SEPT-2018. EXPIRATION DATE: 2023-08-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 27 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0511FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R (K140826) LOT. 146652. BATCH REVIEW PERFORMED ON 28 NOVEMBER 2019: LOT 146652: 24 ITEMS MANUFACTURED AND RELEASED ON 07-APR-2015. EXPIRATION DATE: 2020-02-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A PATELLA RESURFACING SURGERY THE SURGEON NOTICED THAT THE TIBIAL TRAY WAS LOOSE. SINCE A REVISION WITH REVISION IMPLANTS WAS NOT PLANNED, THE SURGEON HAD TO LEAVE THE IMPLANT INTO THE PATIENT. THE REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2019, 5 MONTHS AFTER PRIMARY. THE SURGEON DETECTED INFECTION (THE PATHOGEN IS STAPHYLOCOCCUS AND A SKIN BACTERIA) AND REVISED ALSO THE LINER AND FEMUR OF THE PATIENT IMPLANTING A SPACER. IT IS UNKNOWN AT THE MOMENT IF INFECTION CAUSED THE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221012 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 181946 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention