BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R

    MDR report key: 12787103 · Received November 10, 2021

    Report

    Report Number
    3005180920-2021-00872
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    October 12, 2021
    Report Date
    November 10, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826344
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW WAS PERFORMED ON 19 OCTOBER 2021: LOT 1905123: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JUL-2019. EXPIRATION DATE: 2024-JUN-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW WAS PERFORMED ON 19 OCTOBER 2021: GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED # 3 R (K090988) LOT 1903511: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2019. EXPIRATION DATE: 2024-SEP-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0023R FEMORAL COMPONENT SPHERE CEMENTED # 3+ R (K140826) LOT 178029: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2018. EXPIRATION DATE: 2023-MAR-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR ANTERIOR KNEE PAIN. AT 1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY, A RESURFACING PATELLA SIZE 2 HAS BEEN ADDED, NO IMPLANT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688399 GMK-SPHERE 02.12.0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0310FR 1905123 07630030826344

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other