BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L

    MDR report key: 7938079 · Received October 5, 2018

    Report

    Report Number
    3005180920-2018-00753
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    September 4, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826658
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 OCTOBER 2018; LOT 153758: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 NOVEMEBR 2015. EXPIRATION DATE: 2022-09-24; 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 PATELLA RESURFACING SIZE 2 REFERENCE 02.07.0034RP (K090988); LOT 166110: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 NOVEMBER 2016. EXPIRATION DATE: 2021-11-10; 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

    REVISION SURGERY DUE TO LAXITY 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON SWAPPED THE POLY AND THE PATELLA RESURFACING (LEFT KNEE). THE PATELLA WAS NOT WELL FIXED. SAME PATIENT OF MDR 2018-00750.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780551 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 153758 07630030826658

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention