BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR CEMENTED SIZE 4 LEFT STD

    MDR report key: 6489601 · Received April 13, 2017

    Report

    Report Number
    3005180920-2017-00178
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    March 16, 2017
    Report Date
    July 6, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 09 JUNE 2017 AND INCLUDES: THE REVISION SURGERY WAS NOT RESCHEDULED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 21 MARCH 2017 AND INCLUDES: THE CASE HAS BEEN CANCELED UNTIL FURTHER NOTICE. ADDITIONAL INFORMATION RECEIVED ON 28 MARCH 2017 AND INCLUDES: THE PATIENT DIDN'T HAVE TRAUMA JUST LOOSENING OF SOFT TISSUE. BATCH REVIEWS PERFORMED ON 10 APRIL 2017. LOT 111253: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JUNE 2011. 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-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT, CODE 02.07.1204L, LOT. 111458 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JUNE 2011. EXPIRATION DATE: 2016-04-30. 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-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 14 MM, CODE 02.07.0414FUC, LOT. 091282 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 AUGUST 2009. EXPIRATION DATE: 2014-04-30. 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. GMK-PRIMARY 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. NOT YET EXPLANTED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON SCHEDULED A REVISION WHICH HAD BEEN CANCELED. X-RAYS AND EXPLANTS WILL NOT BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270774 GMK-PRIMARY FEMUR CEMENTED SIZE 4 LEFT STD KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 111253

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention