BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    MDR report key: 8503588 · Received April 11, 2019

    Report

    Report Number
    3005180920-2019-00263
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 11, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 APRIL 2019: LOT 161484: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2016. EXPIRATION DATE: 2021-05-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0025L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L (K140826) LOT 140588: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2015. EXPIRATION DATE: 2019-01-31. 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 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L (K121416) LOT 177402: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2018. EXPIRATION DATE: 2023-02-06. 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. GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT 162488: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 2021-05-31. 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.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2016 AND AFTER 1 YEARS AND 11 MONTHS THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. A POLY SWAP AND WASHOUT WAS PERFORMED (MDR (B)(4)). 7 MONTHS AFTER THE FIRST REVISION, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REVISED THE TIBIAL TRAY, THE LINER, THE FEMORAL COMPONENT AND THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298091 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L KNEE METAL TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 161484 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention