MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L

Model Number	02.12.0003L
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 6 years and 8 months after primary, the patient came in reporting loosening of tibial and femoral components.Moreover, subsidence of the femur is present.The surgeon revised all the components to gmk-hinge system and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 14-may-2025.Lot 179605: (b)(4) items manufactured and released on 25-apr-2018.Expiration date: 17-apr-2023.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: a revision surgery was performed approximately 7 years after the primary tka due to loosening of both the femoral and tibial components.The available pre-revision x-ray images show clear signs of mobilization of the femoral component, which appear tilted anteriorly.Even the tibial component shows sign of loosening (e.G.The sclerotic line surrounding the tibial stem may represent an indirect marker of impaired fixation, which may have caused chronic mechanical stress and reactive bone remodeling).Aseptic loosening is a well-documented adverse event following primary tka, with multifactorial and often unidentified causes.In this specific case, the exact cause of the implant failure cannot be determined.However, there is no evidence to suggest that the prosthetic device was defective.Other device involved: gmk-sphere 02.12.T4i3l tibial tray fixed cemented size t4i3 l (k121416) lot 173665: (b)(4) items manufactured and released on 07-nov-2017.Expiration date: 19-oct-2022.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.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 device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L
• 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: 22192828
• Report Number: 3005180920-2025-00500
• Device Sequence Number: 15662784
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 06/12/2025

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: 04/17/2023
• Device Model Number: 02.12.0003L
• Device Lot Number: 179605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2018
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American