BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 4

    MDR report key: 7897535 · Received September 21, 2018

    Report

    Report Number
    3005180920-2018-00709
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    August 22, 2018
    Report Date
    September 21, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815775
    PMA / PMN Number
    K113571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE 18 SEPTEMBER 2018: PATHOGEN NOT AVAILABLE. LOT 164135: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 SEPTEMBER 2016. EXPIRATION DATE: 2021-09-07. 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. OTHER DEVICES INVOLVED. REFERENCE 02.12.0512FR (K121416)TIBIAL INSERT FIXED SPHERE FLEX #5/12 MM R; LOT 162640: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JULY 2016. EXPIRATION DATE: 2021-07-17; 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. REFERENCE 02.12.0025R (K140826) FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R; LOT 147699: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 JANUARY 2015. EXPIRATION DATE: 2019-11-30; 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. REFERENCE 02.07.1205R (K090988) TIBIAL TRAY FIXED CEMENTED SIZE 5 R; LOT 153500: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 AUGUST 2015. EXPIRATION DATE: 2020-06-30; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 SURGERY ON (B)(6) 2015. THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT WAS SEPTIC. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY AND REVISED THE PATELLA. MDR (2017-00383) WAS FILED. ON (B)(6) 2018 THE PATIENT WAS REVISED AGAIN DUE TO INFECTION, PATHOGEN UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741001 GMK-SPHERE PATELLA RESURFACING SIZE 4 PATELLA RESURFACING JWH MEDACTA INTERNATIONAL SA 164135 07630030815775

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention