BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE FEMORAL COMPONENT CEMENTED # 3 R

    MDR report key: 4964009 · Received July 31, 2015

    Report

    Report Number
    3005180920-2015-00170
    Event Type
    Injury
    Date Received
    July 31, 2015
    Report Date
    November 11, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON JULY 31, 2015: LOT 147471: (B)(4) ITEMS MANUFACTURED AND RELEASED ON DECEMBER 15, 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. LOT 140345: (B)(4) ITEMS MANUFACTURED AND RELEASED ON APRIL 14, 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. ON (B)(4) 2015, WE WERE INFORMED THAT ON (B)(6) 2015, THE PT WENT TO THE SURGEON FOR A MEDICAL EXAMINATION AND THE INSERT AND SCREW APPEAR NORMAL AND THERE IS NO SUBSIDENCE OR LOOSENING. THE SURGEON WAS NOT ABLE TO DISLOCATE THE KNEE AS HE DID ON THE LAST EXAM. THE KNEE WAS PRETTY STABLE IN FULL EXTENSION AND MID FLEXION. THERE WAS SOME CLUNKING AS THE FEMUR WOULD MOVE FORWARD INTO THE ANTERIOR LIP OF THE INSERT. AT THIS TIME, REVISION SURGERY WILL BE POSTPONED TO SEE IF THE JOINT BECOMES MORE STABLE OVER TIME.

    Additional Manufacturer Narrative · 1

    ON 12 OCTOBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INTIAL REPORT. ON THE SAME DAY IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499193 GMK SPHERE FEMORAL COMPONENT CEMENTED # 3 R FEMORAL CEMENTED COMPONENT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1