MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3R

Model Number	02.12.0003R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 8 september 2025: lot 163331: 33 items manufactured and released on 22-jul-2016.Expiration date: 16-jun-2021.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.Clinical evaluation performed by medacta medical affairs director: the femoral component of a total knee arthroplasty (tka), along with the tibial insert, was revised approximately nine years after the primary implantation due to aseptic loosening.The available radiographic images demonstrate clear radiolucent lines, consistent with component loosening.Aseptic loosening is a well-documented complication in the literature, typically associated with multifactorial or unclear etiology.In this case, the exact cause of failure cannot be definitively established based on the available data.However, it is worth noting that two years prior to the revision, the patient sustained a fall that resulted in mobilization of the tibial tray, necessitating surgical intervention.This traumatic event may have contributed to the failure mechanism observed.Although it is not possible to identify a definite root cause based on the available information, the traumatic event that triggered the first revision may also have contributed to this outcome.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.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2016.On (b)(6) 2021, the patient came in for a post-op appointment and it was observed that the tibial insert screw had disengaged and ended up inside of the tissue.It was also observed that the tibial insert screw had caused damage to the unresurfaced patella.The surgeon revised the liner, tibial tray and added an extension stem and patella.The surgery was completed successfully.On (b)(6) 2022, the patient came in for a post-op appointment reporting pain after falling.The surgeon observed that the patient had a loose and subsided tibia.The surgeon revised the tibial tray and insert.The surgery was complete successfully.On (b)(6), 2025, the patient came in reporting pain due to a loose femur and the cause is unknown.The surgeon revised the femur and insert (to an insert of the same size, per standard procedure) and the surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3R
• 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: 23014742
• Report Number: 3005180920-2025-00828
• Device Sequence Number: 15869449
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• 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: 2016
• 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): 09/10/2025

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 Expiration Date: 06/16/2021
• Device Model Number: 02.12.0003R
• Device Lot Number: 163331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2016
• 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 Sex: Female