MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE FEMORAL COMPONENT CEMENTED - 2+L

Model Number	02.12.0022L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs manager: revision surgery was performed approximately 20 months after primary tka was performed due to a limited range of motion.Radiographic assessment shows well-positioned and stable components, without evidence of loosening or mechanical failure.A posterior radiopacity is noted, possibly compatible with capsular thickening, although not definitively assessable.The clinical scenario is consistent with postoperative stiffness, a known multifactorial complication after tka.The intraoperative improvement following posterior capsular release supports a soft-tissue origin.The need for an increased distal femoral resection with unchanged component size suggests an initial extension gap imbalance rather than an issue related to implant sizing or design.Based on the available information, there is no evidence of device malfunction or manufacturing defect.The root cause cannot be determined with certainty and is likely multifactorial.Batch review performed on 27 april 2026: gmk-sphere 02.12.0022l gmk-sphere femoral component cemented - 2+l (k140826) lot 2240007: (b)(4) items manufactured and released on 5-jan-2023.Expiration date: 2027-dec-12.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 02.12.0310fl gmk-sphere tibial insert - flex s3l - 10 mm (k121416) lot 2001699: (b)(4) items manufactured and released on 30-mar-2020.Expiration date: 2025-mar-30.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.Root cause: 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 investigation does not indicate any potential manufacturing related issue.
Event or Problem Description
Revision surgery due to insufficient flexion and extension after total prosthesis at 1 year and 8 months post primary.The posterior capsule was manually released to increase flexion.The tibial component was not revised.Femoral component revised to one of the same size, sphere component with a 4 mm increased distal cut.Inlay revised with the same size and height: stable prothesis and sufficient flexion and extension.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED - 2+L
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25148964
• Report Number: 3005180920-2026-00422
• Device Sequence Number: 10752157
• Product Code: JWH
• UDI-Device Identifier: 07630030862472
• UDI-Public: 07630030862472
• Combination Product (Y/N): N
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.12.0022L
• Device Lot Number: 2240007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female