BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/12 MM R

    MDR report key: 9909609 · Received April 1, 2020

    Report

    Report Number
    3005180920-2020-00207
    Event Type
    Injury
    Date Received
    April 1, 2020
    Date of Event
    March 3, 2020
    Report Date
    April 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826382
    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 06 MARCH 2020: LOT 186065: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2018. EXPIRATION DATE: 2023-12-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED # 3 R LOT. 165052 (K121416). BATCH REVIEW PERFORMED ON 06 MARCH 2020: LOT 165052: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2016. EXPIRATION DATE: 2021-09-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING # 2 LOT. 165518 (K090988). BATCH REVIEW PERFORMED ON 06 MARCH 2020: LOT 165518: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2016. EXPIRATION DATE: 2021-11-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.T4I3R TIBIAL TRAY FIXED CEMENTED # T4-I3 R LOT. 163353 (K121416). BATCH REVIEW PERFORMED ON 06 MARCH 2020: LOT 163353: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2016. EXPIRATION DATE: 2021-06-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2017. ON (B)(6) 2019, THE POLY WAS REVISED BECAUSE OF AN INFECTION. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL HARDWARE AND PROCEEDED TO IMPLANT AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374222 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/12 MM R TIBIAL INSERT FIXED FLEX JWH MEDACTA INTERNATIONAL SA 02.12.0312FR 186065 07630030826382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention