BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 2

    MDR report key: 11919335 · Received June 2, 2021

    Report

    Report Number
    3005180920-2021-00456
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    April 20, 2021
    Report Date
    July 13, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815751
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY (B)(6) ON (B)(6) 2021: FEW MONTHS AFTER PRIMARY CEMENTED TKA RECURRENT DISLOCATION OF THE RESURFACING PATELLA IS LAMENTED BY THE PATIENT. REVISION WILL BE SCHEDULED. WITH THE INFORMATION AT HAND, WE CANNOT DETERMINE THE CAUSE FOR RECURRING DISLOCATION; IT IS LIKELY TO BE DUE TO THE POSITION OF THE COMPONENTS.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28.05.2021: LOT 2001615: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2020. EXPIRATION DATE: 2025-05-06. 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. PATIENT MATCH PLANNING REVIEW: EACH STEP OF THE MYKNEE PROCESS HAS BEEN ANALYZED AND NO ERRORS HAVE BEEN FOUND. OUR ANALYSIS OF THE MYKNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY.

    Description of Event or Problem · 1

    DISLOCATION OF THE RESURFACING PATELLA AFTER PRIMARY SURGERY PERFORMED ON (B)(6) 2020. REVISION SURGERY HAS NOT BEEN PLANNED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816802 GMK-SPHERE PATELLA RESURFACING SIZE 2 PATELLA IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0034RP 2001615 07630030815751

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention