BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 1

    MDR report key: 12148706 · Received July 12, 2021

    Report

    Report Number
    3005180920-2021-00584
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    June 21, 2021
    Report Date
    July 12, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815737
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01.JULY.2021: LOT 2003004: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2020. EXPIRATION DATE: 02-06-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FEW DAYS AFTER PRIMARY TKA THE CPSAULE RUPTURED AND PATELLA DISLOCATED. SURGICAL TREATMENT CONSISTED OF RE-SUTURING OF THE CAPSULE AND CONFIRMATION OF PATELLA TRACKING. NO IMPLANTED OR ANCILLARY DEVICE IS RESPONSIBLE FOR THIS REOPERATION.

    Description of Event or Problem · 1

    PATELLA DISLOCATION WAS OBSERVED 3 DAYS AFTER THE PRIMARY AND 6 DAYS AFTER THE PRIMARY AN ADDITIONAL SURGERY WAS PERFORMED. DURING THE ADDITIONAL SURGERY, THE SURGEON CONFIRMED THE JOINT CAPSULE RAPTURE. THE SURGEON SUTURED THE RAPTURED JOINT CAPSULE AND CONFIRMED PATELLA TRACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046046 GMK-SPHERE PATELLA RESURFACING SIZE 1 PATELLAR IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0033RP 2003004 07630030815737

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention