BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 5 L

    MDR report key: 8105811 · Received November 27, 2018

    Report

    Report Number
    3005180920-2018-00947
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    October 29, 2018
    Report Date
    April 10, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820236
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 13, 2019 WE RECEIVED THE NOTIFICATION OF A NEW COMPLAINT (B)(4), ORIGINALLY REGISTERED DUE TO MISTAKE, AS IT WAS NOT DETECTED AS A DUPLICATE OF THE CURRENT CASE. THE NEW INFORMATION RECEIVED ARE CONSEQUENTLY ADDED TO THIS MDR: "THE PATIENT CAME IN COMPLAINING OF MID-FLEXION INSTABILITY. THE SURGEON REMOVED ALL MEDACTA IMPLANTS ON (B)(6) 2019 AND REVISED THE KNEE WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY".

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 NOVEMBER 2018: LOT 135484: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 DECEMBER 2013. EXPIRATION DATE: 2018-11-30. 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 TIBIAL TRAY FIXED CEMENTED SIZE 5 L REFERENCE 02.07.1205L (K090988). LOT 153511: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 OCTOBER 2015. EXPIRATION DATE: 2020-08-31. 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 INSERT UC FIXED SIZE 5 / 10 MM REFERENCE 02.07.0510FUC (K090988). LOT 147976: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 APRIL 2015. EXPIRATION DATE: 2020-03-31. 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-PRIMARY PATELLA RESURFACING SIZE 3 REFERENCE 02.07.0035RP (K090988). LOT 154112: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 OCTOBER 2015. EXPIRATION DATE: 2020-10-06. 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.

    Description of Event or Problem · 1

    THE PATIENT CALLED FDA TO REPORT THAT SINCE HE HAS BEEN IMPLANTED WITH A TOTAL KNEE IMPLANT, HE HAS HAD PAIN, DISCOMFORT AND LOSS OF RANGE OF MOTION; THE IMPLANT IS AT TEN PERCENT DEFLEXION. THE REPORTER HAS BEEN TOLD BY THREE HEALTHCARE "PROFESSIONAL" THAT HIS KNEE IMPLANT IS UNSTABLE AND EXPLORATORY SURGERY IS NEEDED. "THERE ARE NO RECORD" OF THE REVISION SURGERY BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945723 GMK-PRIMARY FEMUR STD CEMENTED SIZE 5 L FEMUR CEMENTED JWH MEDACTA INTERNATIONAL SA 135484 07630030820236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention