BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE FEMORAL COMPONENT

    MDR report key: 7142937 · Received December 22, 2017

    Report

    Report Number
    3005180920-2017-00766
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 22, 2017
    Report Date
    March 23, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825897
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED BY THE SALES AGENT ON 22 FEBRUARY 2018 BY THE SALES REPRESENTATIVE REVISION WAS PERFORMED ON THE (B)(6) 2017 AND WAS COMPLETED SUCCESSFULLY BY CHANGING THE FEMORAL COMPONENT. REVISION WAS REQUIRED DUE TO MALALIGNMENT OF THE FEMORAL COMPONENT. THIS WAS DUE TO EXCESS CEMENT MANTLE ON THE MEDIAL SIDE OF THE IMPLANT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 27 FEBRUARY 2018 EARLY PARTIAL REVISION (FEMORAL COMPONENT ONLY, 9 MONTHS) OF CEMENTED TKA. ACCORDING TO REPORT, THE CAUSE IS MISALIGNMENT DUE TO EXCESSIVELY THICK CEMENT MANTLE ON THE MEDIAL SIDE. THIS PROBLEM IS NOT RELATED TO A COMPONENT MALFUNCTION OR DEFECT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 DECEMBER 2017. LOT 152871: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 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 TIBIAL INSERT FIXED FLEX #6/12 MM L REF. 02.12.0612FL, LOT. 144617 (K121416): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 OCT 2014. EXPIRATION DATE: 2019-08-31 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 TIBIAL TRAY FIXED CEMENTED # 6 L REF. 02.07.1206L, LOT. 142707 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 JULY 2014. EXPIRATION DATE: 2019-06-30 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. GMK PRIMARY EXTENSION STEM Ø11MM / L 30 MM REF 02.07.F11030 LOT. 153526 (K133630): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JUNE 2015. EXPIRATION DATE: 2018-02-28. 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

    PATIENT HAS REPORTED PAIN AND DISCOMFORT. REVISION WILL OCCUR ON THE (B)(6) 2017. MORE DETAILS TO FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922094 GMK SPHERE FEMORAL COMPONENT CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 152871 07630030825897

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention