MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL COMPONENT CEMENTED T3I4L

Model Number	02.12.T3I4L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary surgery performed on the (b)(6) 2020.Implantation of gmk-sphere components without patella resurfacing.First revision surgery performed on the (b)(6) 2020 due to anterior pain described by the patient and laxity of the knee.Implantation of a resurfacing patella size 2.The 12mmliner was revised witha 14mm liner.Second revision surgery performed on the (b)(6) 2026.Loosening of the femoral and tibial components.No infection.Explantation of the femoral and tibial components with liner.Reimplantation of gmk-revision implants with extension stems, offsets and wedges.Event also related to (b)(4).
Additional Manufacturer Narrative
Batch review performed on 25 feb 2026.Gmk-sphere 02.12.T3i4l gmk-sphere tibial component cemented t3i4l (k121416) lot 1904612: (b)(4) items manufactured and released on 18/sept/2019.Expiration date: 07/sept/2024.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0004l gmk-sphere femoral component cemented - 4l (k121416) lot 1904574: (b)(4) items manufactured and released on 27/08/2019.Expiration date: 27/07/2024.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.Clinical evaluation performed by clinical affairs departement a revision surgery was performed approximately six years after implantation of a total knee arthroplasty (tka).According to the report, the indication for revision was loosening of the femoral and tibial components.The available radiographic images are of suboptimal quality, which makes the assessment of potential radiolucent lines or other signs of loosening difficult.A possible radiolucent line may be present along the lateral aspect of the tibial component.Aseptic loosening is a known complication described in the literature following primary tka, often with multifactorial or unclear etiology.Based on the information currently available, the precise cause of this failure cannot be determined.At present, there is no evidence to suggest a malfunction or manufacturing defect of the prosthetic implant.Root cause:aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL COMPONENT CEMENTED T3I4L
• 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: 24603553
• Report Number: 3005180920-2026-00204
• Device Sequence Number: 18518341
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• Combination Product (Y/N): N
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 03/16/2026

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 Expiration Date: 09/07/2024
• Device Model Number: 02.12.T3I4L
• Device Lot Number: 1904612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 111 KG