BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ RIGHT

    MDR report key: 6944542 · Received October 12, 2017

    Report

    Report Number
    3005180920-2017-00578
    Event Type
    Injury
    Date Received
    October 12, 2017
    Report Date
    October 12, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 12 OCTOBER 2017. LOT 165997: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 NOVEMBER 2016. EXPIRATION DATE: 2021-11-09. 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 TIBIAL INSERT FIXED FLEX SIZE 2/20 MM RIGHT, CODE 02.12.0220FR, LOT. 146637 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 JUNE 2015. EXPIRATION DATE: 2020-05-31. 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-SPHERE FEMORAL WEDGE DISTAL SIZE 3/4MM, CODE 02.07.304FDW, LOT. 151201 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 MAY 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. GMK-SPHERE FEMORAL WEDGE POSTERIOR SIZE 3/10MM, CODE 02.07.310FPW, LOT. 102529 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 OCTOBER 2010. EXPIRATION DATE: 2020-11-10. 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 EXTENSION STEM - FLUTED Ø 11 L 65, CODE 02.07.FCL11065, LOT. 161029 (K120790) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 APRIL 2016. EXPIRATION DATE: 2021-04-07. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE PATIENT IS PRESENTING WITH LIGAMENTOUS INSTABILITY. THE CAUSE IS UNKNOWN. THE SURGEON IS REQUESTING A CUSTOM INSERT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724925 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ RIGHT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 165997 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention