BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/17 MM R

    MDR report key: 13693112 · Received March 8, 2022

    Report

    Report Number
    3005180920-2022-00163
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    February 8, 2022
    Report Date
    March 8, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826269
    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 08-MARCH-2022: LOT 153767: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2015. EXPIRATION DATE: 2020-10-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT 4 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY WHERE IT WAS OBSERVED THAT THE PATIENT HAD A BONE SPUR (OSTEOPHYTES). THE SURGEON REMOVED THE BONE SPUR AND UPSIZED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926261 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/17 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0217FR 153767 07630030826269

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention