BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 6 R

    MDR report key: 15665112 · Received October 25, 2022

    Report

    Report Number
    3005180920-2022-00781
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    September 26, 2022
    Report Date
    October 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821479
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. ALMOST 10 YEARS AFTER REVISION KNEE ARTHROPLASTY IN AN OVERWEIGHT PATIENT, PAIN AND PATELLAR OVERLOAD REQUIRE AN EXCHANGE TO A MORE CONSTRAINED DEVICE. IT IS VERY LIKELY, FROM THE INFORMATION RECEIVED, THAT THE CHANGE IS POSTULATED BECAUSE OF DISEASE PROGRESSION RATHER THAN IMPLANT MALFUNCTION. BATCH REVIEW PERFORMED ON 24 OCTOBER 2022: LOT 113210: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2011. EXPIRATION DATE: 2016-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: GMK-REVISION 02.07.FCL13065 EXTENSION STEM - FLUTED Ø 13 L 65 (K120790) LOT 115703: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-AUG-2012. EXPIRATION DATE: 2017-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.16TW TIBIAL WEDGE SIZE 6/10MM (K1024379 LOT. 082568: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2008. EXPIRATION DATE: 2013-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.1206R FIXED TIBIAL TRAY CEMENTED SIZE 6 R (K090988) LOT 113397: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2011. EXPIRATION DATE: 2016-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.0005 OFFSET CONNECTOR 5 MM (K102437) LOT. 120330: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2012. EXPIRATION DATE: 2017-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.0610PSF TIBIAL INSERT PS FIXED SIZE 6/10MM (K090988) LOT. 114238: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2012. EXPIRATION DATE: 2016-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO PAIN AND PATELLOFEMORAL OVERLOAD WITH CHRONIC EXTENSION DEFICIT. GMK HINGE WAS IMPLANTED SUCCESSFULLY. EXPLANTS WERE IMPLANTED IN A REVISION SURGERY IN 2012, AFTER UNICONDYLAR IMPLANTATION IN 2008. INLAY EXCHANGE AND PATELLAR RESURFACING WAS PERFORMED IN 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391160 GMK-REVISION FEMUR REVISION PS SIZE 6 R KNEE REVISION FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.2406R 113210 07630030821479

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention