BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED # 3+ L

    MDR report key: 7112597 · Received December 13, 2017

    Report

    Report Number
    3005180920-2017-00738
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862373
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 165045: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 SEPT 2016. EXPIRATION DATE: 2021-09-13 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-SPHERE 02.12.0310FL TIBIAL INSERT FIXED FLEX #3/10 MM L (K121416): LOT 164024: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 SEPT 2016. EXPIRATION DATE: 2021-09-04 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-SPHERE 02.07.1203L TIBIAL TRAY FIXED CEMENTED # 3 L (K090988): LOT 164089: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPT 2016. EXPIRATION DATE: 2021-09-15 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0033RP PATELLA RESURFACING # 1 (K090988) : LOT. 163382: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 OCTOBER 2016. EXPIRATION DATE: 2021-09-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 54 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 13 DECEMBER 2017: TOTAL KNEE REVISION SURGERY OCCURRED 1 YEAR AFTER IMPLANTATION. ACCORDING TO THE REPORT, THE IMPLANT WAS IN VALGUS POSITION BUT THIS CANNOT BE ASSESSED HAVING ONLY POST-REVISION X-RAYS. ON THE BASIS OF AVAILABLE INFORMATION, A PROPER CLINICAL EVALUATION CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE PATIENT PRESENTED WITH A VALGUS KNEE. THE SURGEON REVISED ALL MEDACTA HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892352 GMK-SPHERE FEMORAL COMPONENT CEMENTED # 3+ L FEMORAL CEMENTED COMPONENT JWH MEDACTA INTERNATIONAL SA 165045 07630030862373

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention