MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L

Model Number	02.12.0310FL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Bilateral tka performed on (b)(6) 2017.In (b)(6) 2021, the patient had pain in the left knee and x-rays showed that the inlay locking screw had loosened and was free in the anterior part of the joint.The screw was then removed arthroscopically on (b)(6) 2021.During the surgery, signs of metallosis were seen in the soft tissues, and the femoral component and pe inlay had signs of damage.After the surgery, the patient had persistent pain in the left knee and radiographic controls showed the presence of small intra-articular third bodies, probably metal debris from the screw or fragments of surgical instruments.No other information available.Torque limiter was not available during the primary surgery.
Additional Manufacturer Narrative
Batch review performed on 14 may 2025.(b)(4) items manufactured and released on 21/11/2016.Expiration date: 07/11/2021.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.Additional devices involved: gmk-sphere 02.07.1203l tibial tray fixed cemented szie 3 l (k090988) lot.165483 batch review performed on 14 may 2025.(b)(4) items manufactured and released on 09/12/2016.Expiration date: 28/11/2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold.Gmk-sphere 02.12.0023l femoral component sphere cemented size 3+ l (k140826) lot.165045 batch review performed on 14 may 2025.(b)(4) items manufactured and released on 09/12/2016.Expiration date: 28/11/2021.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.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM 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: 22094478
• Report Number: 3005180920-2025-00516
• Device Sequence Number: 6935570
• Product Code: JWH
• UDI-Device Identifier: 07630030826337
• UDI-Public: 07630030826337
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• 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): 05/28/2025

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: 11/07/2021
• Device Model Number: 02.12.0310FL
• Device Lot Number: 166017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2016
• 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