BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION, FEMUR REVISION PS #5 R

    MDR report key: 5353853 · Received January 8, 2016

    Report

    Report Number
    3005180920-2015-00365
    Event Type
    Injury
    Date Received
    January 8, 2016
    Date of Event
    December 9, 2015
    Report Date
    February 9, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 11 JANUARY 2016 INCLUDES: THE PATHOGEN RESULTS WILL NOT BE RELEASED TO US. ON 09 FEBRUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION REPORTED IN THE INITIAL REPORT AND HERE ABOVE. ON THE SAME DAY IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 100573: 20 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2010. EXPIRATION DATE: 2015-06-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK TIBIAL INSERT PS FIXED # 4/14MM, CODE 02.07.0414PSF, LOT. 121392 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2012. EXPIRATION DATE: 2017-04-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK TIBIAL TRAY FIXED CEMENTED # 4 R, CODE 02.07.1204R, LOT. 121651 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2012. EXPIRATION DATE: 2017-06-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION EXTENSION STEM - CEMENTED Ø 13 L 65, CODE 02.07.FSC13065, LOT. 115058 (K120790): (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2012. EXPIRATION DATE: 2017-03-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION EXTENSION STEM - CEMENTED Ø 16 L 65, CODE 02.07.FSC16065, LOT. 115062 (K120790): (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6)2012. EXPIRATION DATE: 2017-02-28. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION TIBIAL WEDGE # 4/10MM, CODE 02.07.14TW, LOT. 100593 (K102437): (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2010. EXPIRATION DATE: 2015-04-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. 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. 114421 (K102437): (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2012. EXPIRATION DATE: 2016-12-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE 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. 115028 (K102437): (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2012. EXPIRATION DATE: 2016-12-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. 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

    ON (B)(6) 2015 THE PATIENT PRESENTED WITH SIGNS OF INFECTION. THE SURGEON DECIDED TO PERFORM A 2 STAGE REVISION. ALL IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE PUT IN. THE EXPLANTS WILL NOT BE RETURNED. THERE ARE NO X-RAYS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13103 GMK-REVISION, FEMUR REVISION PS #5 R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 100573

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention