BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE FEMORAL COMPONENT SIZE 4 LEFT

    MDR report key: 5476933 · Received March 3, 2016

    Report

    Report Number
    3005180920-2016-00069
    Event Type
    Injury
    Date Received
    March 3, 2016
    Date of Event
    January 25, 2016
    Report Date
    June 1, 2016
    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

    BATCH REVIEW PERFORMED ON 29 FEBRUARY 2016. GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 LEFT, CODE 02.12.0004L, LOT. 141227 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MARCH 2014. EXPIRATION DATE: 2019-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #4/12 MM LEFT, CODE 02.12.0412FL, LOT. 141018 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 MARCH 2014. EXPIRATION DATE: 2019-02-28. 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 T3-I4 LEFT, CODE 02.12.T3I4L, LOT. 142563 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 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. GMK PRIMARY EXTENSION STEM CODE 02.07.F11066, LOT 141649 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 MAY 2014. EXPIRATION DATE: 2019-03-31. 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 PATELLA RESURFACING SIZE 3, CODE 02.07.0035RP, LOT. 148621 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 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.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DATE THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH SIGNS OF INFECTION. THE SURGEON REMOVED ALL IMPLANTS AND PUT IN ANTIBIOTIC SPACERS. THE PATIENT TESTED POSITIVE FOR CORYNEBACTERIUM. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE ARE NO X-RAYS. THE EXPLANTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132298 GMK SPHERE FEMORAL COMPONENT SIZE 4 LEFT CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 141227

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention