BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 3 RIGHT

    MDR report key: 6579281 · Received May 19, 2017

    Report

    Report Number
    3005180920-2017-00256
    Event Type
    Injury
    Date Received
    May 19, 2017
    Date of Event
    April 19, 2017
    Report Date
    May 19, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 26 APRIL 2017 AND INCLUDES: THE SURGEON DETERMINED THE IMPLANTS WERE IMPROPERLY IMPLANTED FROM THE FIRST REVISION WHICH WAS CAUSING STIFFNESS AND PAIN FOR THE PATIENT. BATCH REVIEWS PERFORMED ON 15 MAY 2017. LOT 102567: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 NOVEMBER 2010. EXPIRATION DATE: 2015-10-31. 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-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 RIGHT, CODE 02.07.1203R, LOT. 111046 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 MAY 2011. EXPIRATION DATE: 2016-03-31. 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-REVISION FIXED TIBIAL INSERT SC SIZE 3/14MM, CODE 02.07.0314SCF, LOT. 110062 (K103170) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 APRIL 2011. EXPIRATION DATE: 2016-02-29. 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-REVISION PATELLA RESURFACING SIZE 2, CODE 02.07.0034RP, LOT. 112017 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON GG MONTH AAAA. EXPIRATION DATE: 2016-05-31. 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-REVISION OFFSET CONNECTOR 3 MM, CODE 02.07.0003, LOT. 110150 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 APRIL 2011. EXPIRATION DATE: 2016-03-31. 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-REVISION OFFSET CONNECTOR 5 MM, CODE 02.07.0005, LOT. 110151 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 APRIL 2011. EXPIRATION DATE: 2016-02-29.. 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-REVISION EXTENSION STEM Ø11MM / L 65 MM, CODE 02.07.F11065, LOT. 110135 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 APRIL 2011. EXPIRATION DATE: 2016-03-31. 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-REVISION EXTENSION STEM Ø16MM / L 65 MM, CODE 02.07.F16065, LOT. 101838 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JULY 20010. EXPIRATION DATE: 2015-05-31. 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-REVISION FEMORAL WEDGE POSTERIOR SIZE 3/5MM, CODE 02.05.03PW, LOT. 102535 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 OCTOBER 2010. EXPIRATION DATE: 2015-09-30. 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. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON SUSPECTED POOR IMPLANT POSITIONING AND DECIDED TO REVISE THE ALL MEDACTA COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. AFTER SURGERY, THE SURGEON CONFIRMED THAT THE IMPLANTS WERE IMPROPERLY IMPLANTED FROM THE FIRST REVISION WHICH WAS CAUSING STIFFNESS AND PAIN FOR THE PATIENT. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359753 GMK-REVISION FEMUR REVISION PS SIZE 3 RIGHT KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 102567

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention