BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    MDR report key: 16467869 · Received March 2, 2023

    Report

    Report Number
    3005180920-2023-00094
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    February 1, 2023
    Report Date
    May 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862380
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 FEBRUARY 2023. LOT 2210192: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2022. EXPIRATION DATE: 2027-JUL-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 02 FEBRUARY 2023: GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT. 2209919. LOT 2209919: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2022. EXPIRATION DATE: 2027-JUN-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    THE EVENT DESCRIPTION HAS BEEN MODIFIED TO REPORT THAT THE TIBIAL COMPONENT HAS NOT BEEN REVISED.

    Description of Event or Problem · 0

    ABOUT 1 MONTH AND 10 DAYS AFTER PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A CAPSULE TEAR, DISLOCATED PATELLA IMPLANT, AND SUBSIDED FEMORAL COMPONENT. THE PATELLA DISLOCATED DUE TO THE CAPSULE TEAR AND SUBSIDENCE OF THE FEMORAL COMPONENT, WHICH CAUSED THE ROTATION TO BE OFF. THE SURGEON BELIEVES THIS HAPPENED BECAUSE THE PATIENT HAD A SOFT BONE. THE SURGEON REVISED ALL COMPONENTS TO REVISION SYSTEM (PATELLA IMPLANT NOT REVISED).

    Description of Event or Problem · 0

    ABOUT 1 MONTH AND 10 DAYS AFTER PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A CAPSULE TEAR, DISLOCATED PATELLA IMPLANT, AND SUBSIDED FEMORAL COMPONENT. THE PATELLA DISLOCATED DUE TO THE CAPSULE TEAR AND SUBSIDENCE OF THE FEMORAL COMPONENT, WHICH CAUSED THE ROTATION TO BE OFF. THE SURGEON BELIEVES THIS HAPPENED BECAUSE THE PATIENT HAD A SOFT BONE. THE SURGEON REVISED FEMUR AND INSERT TO REVISION SYSTEM (PATELLA IMPLANT NOT REVISED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515755 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0023R 2210192 07630030862380

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention