MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE IMPLANTS; 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 Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 october 2025.Lot 2215645: (b)(4) items manufactured and released on 04-nov-2022.Expiration date: 20-oct-2027.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.Conclusion: aseptic loosening is an adverse event that may occasionally happen, as described in scientific literature.No final conclusion can be drawn on the origin of this problem with the information in our hands.
Event or Problem Description
Two years and eight months after the primary surgery, the patient presented with pain due to tibial loosening.The surgeon revised the femoral, tibial, and insert components with tinbn-coated implants.The surgery was completed successfully.

• Brand Name: GMK SPHERE IMPLANTS
• Common Device Name: GMK-SPHERE TIBIAL COMPONENT CEMENTED T3I4L
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 23347369
• Report Number: 3005180920-2025-01057
• Device Sequence Number: 7808534
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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.T3I4L
• Device Lot Number: 2215645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White