BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 25160332 · Received May 13, 2026

    Report

    Report Number
    3005180920-2026-00425
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 13, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825828
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 MAY 2026 GMK-SPHERE 02.12.0003R GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3R (K121416) LOT. 152876: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 JULY 2015. EXPIRATION DATE: 31 MAY 2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 59 ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.1203R TIBIAL TRAY FIX CEMENTED S.3R (K090988) LOT. 152809: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 SEPTEMBER 2015. EXPIRATION DATE: 31 AUGUST 2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0310FR GMK-SPHERE TIBIAL INSERT - FLEX S3R - 10 MM LOT. 153768: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 NOVEMBER 2015. EXPIRATION DATE: 18 OCTOBER 2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION THIS CASE DESCRIBES A LATE FAILURE OF A REVISION TOTAL KNEE ARTHROPLASTY, CHARACTERIZED BY PAIN AND PROGRESSIVE INSTABILITY ASSOCIATED WITH MEDIAL COLLATERAL LIGAMENT (MCL) AND POSTERIOR CRUCIATE LIGAMENT (PCL) INCOMPETENCE. RADIOGRAPHIC FINDINGS SHOW LIMITED RADIOLUCENT LINES AT THE TIBIAL INTERFACE, WITHOUT EVIDENCE OF GROSS MIGRATION. ALTHOUGH SUCH FINDINGS MAY BE SUGGESTIVE OF INTERFACE CHANGES, THE AVAILABLE CLINICAL INFORMATION EXPLICITLY REPORTS ABSENCE OF IMPLANT LOOSENING. FROM STANDARD RADIOGRAPHIC IMAGES NO INFERENCE CAN BE MADE ON THE STATUS OF THE SOFT TISSUE. THE OVERALL CLINICAL PICTURE IS MOST CONSISTENT WITH A WELL-KNOWN COMPLICATION FOLLOWING TOTAL KNEE ARTHROPLASTY, NAMELY INSTABILITY. THIS CONDITION MAY DEVELOP OVER TIME AS A CONSEQUENCE OF PROGRESSIVE SOFT TISSUE INSUFFICIENCY, WITH LIGAMENTOUS STRUCTURES POTENTIALLY STRETCHING OR BECOMING INCOMPETENT, LEADING TO INADEQUATE JOINT STABILITY. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST A DEVICE MALFUNCTION OR MANUFACTURING DEFECT. THE ROOT CAUSE IS MOST LIKELY MULTIFACTORIAL, PREDOMINANTLY RELATED TO LIGAMENTOUS FAILURE AND LONG-TERM BIOMECHANICAL CHANGES. ROOT CAUSE: KNEE INSTABILITY IS A KNOWN POSSIBLE COMPLICATION FOLLOWING PRIMARY KNEE ARTHROPLASTY, OFTEN RELATED TO NATURAL SOFT TISSUE DEGRADATION. ALTHOUGH NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY DEVICE-RELATED ISSUE CAUSED OR CONTRIBUTED TO THE EVENT. IN ADDITION, THE DOCUMENTATION REVIEW DID NOT IDENTIFY ANY POTENTIAL MANUFACTURING-RELATED CAUSE.

    Description of Event or Problem · 0

    REVISION SURGERY AFTER 9 YEARS AND 7 MONTHS DUE TO PERSISTENT INSTABILITY. INTRAOPERATIVE FINDINGS REVEALED NO EVIDENCE OF IMPLANT LOOSENING OR INFECTION, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON REVISED ALL MEDACTA IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339721 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3R JWH MEDACTA INTERNATIONAL SA 02.12.0003R 152876 07630030825828

    Patients

    Seq Age Sex Outcome Treatment
    1