BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED # 4 R

    MDR report key: 4964000 · Received July 31, 2015

    Report

    Report Number
    3005180920-2015-00161
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 7, 2015
    Report Date
    October 30, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER COMPONENT EXPLANTED: GMK-SPHERE 02.07.0035RP PATELLA RESURFACING # 3 LOT # 133345 (K090988). BATCH REVIEW PERFORMED ON JULY 31, 2015. REF. 02.12.0004R LOT 135727: (B)(4) ITEMS MANUFACTURED AND RELEASED ON NOVEMBER 28, 2013. NO ANOMALIES FOUND RELATED TO THE EVENT. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. REF. 02.07.1204R, LOT 134259: 46 ITEMS MANUFACTURED AND RELEASED ON NOVEMBER 8, 2013. NO ANOMALIES FOUND RELATED TO THE EVENT. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. REF. 02.12.0410FR, LOT 135742: (B)(4) ITEMS MANUFACTURED AND RELEASED ON FEBRUARY 13, 2014. NO ANOMALIES FOUND RELATED TO THE EVENT. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. REF 02.07.0035RP, LOT 133345: (B)(4) ITEMS MANUFACTURED AND RELEASED ON SEPTEMBER 24, 2013. NO ANOMALIES FOUND RELATED TO THE EVENT. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    ON 30 SEPTEMBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INTIAL REPORT. ON 28 OCTOBER 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    IMP # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498981 GMK-SPHERE FEMORAL COMPONENT CEMENTED # 4 R FEMORAL CEMENTED COMPONENT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention