BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM R

    MDR report key: 12951285 · Received December 7, 2021

    Report

    Report Number
    3005180920-2021-00949
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    November 8, 2021
    Report Date
    December 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826825
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 NOVEMBER 2021: LOT 154789: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-FEB-2016. EXPIRATION DATE: 2021-01-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 15 NOVEMBER 2021. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2(K090988)LOT 180309: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2018. EXPIRATION DATE: 2023-04-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVE

    Description of Event or Problem · 0

    AT 1 YEAR 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS DUE TO A FLEXION CONTRACTURE. THE CAUSE OF THE FLEXION CONTRACTURE IS UNKNOWN. THE SURGEON REVISED THE POLY (14 MM TO 13 MM) AND ALSO REVISED THE PATELLA TO BE MORE LATERAL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855332 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM R TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0514FR 154789 07630030826825

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention