BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 RIGHT

    MDR report key: 6525645 · Received April 27, 2017

    Report

    Report Number
    3005180920-2017-00216
    Event Type
    Injury
    Date Received
    April 27, 2017
    Date of Event
    March 31, 2017
    Report Date
    June 8, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 16 MAY 2017 AND INCLUDES: THE FEMUR WAS REVISED BECAUSE IT WOULD NOT HAVE HELPED. A STEMMED COMPONENT AND A CONSTRAINED LINER WERE NEEDED AND THE ORIGINAL FEMUR WAS NOT COMPATIBLE. ON 17 MAY 2017 THE RAND D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: - EXPLANTED FEMORAL COMPONENT: SOME RESIDUAL CEMENT IS PRESENT ON THE INTERNAL SURFACES OF THE FEMORAL COMPONENT. THE FEMORAL COMPONENT SEEMS TO BE IN COMPLIANCE WITH THE SPECIFICATIONS REQUIRED IN TERMS OF INTERNAL AND ARTICULAR SURFACE FINISHING. - EXPLANTED TIBIA INSERT: THE INSERT PRESENTS SOME DENTS AND SCRATCHES ON THE DISTAL SURFACE, MOST LIKELY CAUSED DURING THE EXPLANTATION OF THE COMPONENT. THE ARTICULAR SURFACE IS REGULARLY WORN OUT AFTER ONE YEAR FROM PRIMARY SURGERY. NO ELEMENTS THAT MAY LEAD US SUSPECT FOR A FAULTY DEVICE ARE PRESENT. AS REPORTED IN THE EVENT DESCRIPTION, CAUSE FOR REVISION WAS SOFT TISSUE INSTABILITY AND WAS NOT IMPLANT RELATED.

    Additional Manufacturer Narrative · 1

    ON 21 APRIL 2017, THE PATIENT MATCH DEPARTMENT PERFORMED A PLANNING REVIEW AND COMMENTED AS FOLLOWS: OUR ANALYSIS OF THE PLANNING PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. BATCH REVIEWS PERFORMED ON 24 APRIL 2017. LOT 142546: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 MAY 2014. EXPIRATION DATE: 2019-03-31. 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 TIBIAL INSERT FIXED FLEX SIZE 3/10 MM RIGHT, CODE 02.12.0310FR, LOT. 153308 (K121416) LOT 153308: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 OCTOBER 2015. EXPIRATION DATE: 2020-09-21. 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 INSTABILITY. THE INSTABILITY WAS CAUSED BY SOFT TISSUE INSTABILITY. THE CAUSE OF THE SOFT TISSUE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306784 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 RIGHT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 142546

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention