BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    MDR report key: 7540697 · Received May 24, 2018

    Report

    Report Number
    3005180920-2018-00355
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    April 23, 2018
    Report Date
    May 24, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 MAY 2018. LOT 165027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 NOVEMBER 2016. EXPIRATION DATE: 2021-10-27 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 TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L REFERENCE 02.12.0413FL (K140826) LOT 154371: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 SEPTEMBER 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-SPHERE PATELLA RESURFACING SIZE 2 REFERENCE 02.07.0034RP (K090988) LOT 166108: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 NOVEMBER 2016. EXPIRATION DATE: 2021-11-09 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 FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L REFERENCE 02.12.0005L (K121416) LOT 165986: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 NOVEMBER 2016. EXPIRATION DATE: 2021-11-13 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

    ABOUT 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A INFECTION. ALL THE DEVICE REPLACED SUCCESSFULLY AFTER A PERIOD WITH A SPACER IMPLANTED. PATHOGEN NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385736 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 165027 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention