BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 RIGHT

    MDR report key: 6449461 · Received March 31, 2017

    Report

    Report Number
    3005180920-2017-00152
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    March 3, 2017
    Report Date
    May 3, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 AND INCLUDES: THE REVISION ROOT CAUSE WAS CONFIRMED AS KNEE PAIN AND THE REVISION WAS PERFORMED ON (B)(6) 2017. THE PAIN REASON IS NOT DETERMINABLE. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 15 MARCH 2017 AND INCLUDES: THE PATIENT HAS PATELLA PAIN. THE REVISION IS SCHEDULED FOR (B)(6) 2017. ON 17 MARCH 2017 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: MALE PATIENT WITH A CEMENTED TKA SINCE 1,5 YEARS. THE PROSTHETIC COMPONENTS LOOK PERFECTLY IMPLANTED, BUT THE PATELLA DOES NOT SIT PROPERLY IN THE SPECIAL GROOVE ON THE FEMORAL COMPONENT. THIS IS MOST PROBABLY THE CAUSE FOR ANTERIOR PAIN. THE CAUSE FOR THIS INCONVENIENCE DOES NOT LIE IN A DEFECTIVE DEVICE. BATCH REVIEWS PERFORMED ON 27 MARCH 2017. LOT 150390:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 APRIL 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 TIBIAL TRAY FIXED CEMENTED SIZE 5 RIGHT, CODE 02.07.1205R, LOT. 152821 (K090988) LOT 152821: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 JULY 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 SIZE 5/12 MM RIGHT, CODE 02.12.0512FR, LOT. 143398 (K121416) LOT 143398: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 JULY 2014. EXPIRATION DATE: 2019-05-31. 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. NOT YET EXPLANTED.

    Description of Event or Problem · 1

    REVISION SURGERY PLANNED BECAUSE THE PATIENT HAD PATELLA PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231491 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4 RIGHT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 150390

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention