BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22792531 · Received August 13, 2025

    Report

    Report Number
    3005180920-2025-00764
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 13, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862403
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 JUL 2025. GMK-SPHERE 02.12.0024R GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4+R (K140826) LOT 2403843: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2024. EXPIRATION DATE: 2029-02-21. 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 COMPONENTS INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 31 JUL 2025. GMK-SPHERE 02.12.E002RP GMK-SPHERE RESURFACING PATELLA E-CROSS - S2 (K202022) LOT 2430992: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2025. EXPIRATION DATE: 2030-01-13. 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. BATCH REVIEW PERFORMED ON 31 JUL 2025. GMK-SPHERE 02.12.E0410FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 10MM (K202022) LOT 2434069: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2025. EXPIRATION DATE: 2030-01-09. 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. BATCH REVIEW PERFORMED ON 31 JUL 2025. GMK-SPHERE 02.12.T3I4R GMK-SPHERE TIBIAL COMPONENT CEMENTED T3I4R (K121416) LOT 2424630: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JAN-2025. EXPIRATION DATE: 2029-12-11. 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. CONCLUSIONS: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    PATIENT CALLED MEDACTA REPORTING PAIN AT ABOUT 3 MONTHS AFTER A PRIMARY TOTAL KNEE REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME AND THE SURGEON DOES NOT HAVE ANY PLANS TO REVISE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66080 GMK SPHERE TOTAL KNEE SYSTEM FEMUR SPHERE CEMENTED RIGHT, SIZE 4+ JWH MEDACTA INTERNATIONAL SA 02.12.0024R 2403843 07630030862403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention