BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    MDR report key: 7544744 · Received May 25, 2018

    Report

    Report Number
    3005180920-2018-00368
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    April 25, 2018
    Report Date
    May 25, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 MAY 2018: LOT 147697: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 FEBRUARY 2015. EXPIRATION DATE: 2019-12-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R REFERENCE 02.07.1202R (K090988); LOT 162182: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MAY 2016. EXPIRATION DATE: 2021-05-08. NO ANOMALIES FOUND RELATED TO THE ISSUE. 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 160950: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 MAY 2016. EXPIRATION DATE: 2021-04-25. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM R REFERENCE 02.12.0214FR (K121416); LOT 168343: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 FEBRUARY 2017. EXPIRATION DATE: 2022-02-09. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 1 YEAR AND 9 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT JOINT FOR A INFECTION. ALL THE DEVICES SWAPPED SUCCESSFULLY. THE PATHOGEN IS STAPHYLOCOCCUS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387865 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 147697 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention