MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA; GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R

Model Number	02.07.1204R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29-jan-2025: lot 2111931: (b)(4) items manufactured and released on 05-jan-2022.Expiration date: 15-dec-2026.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.Other devices involved: gmk-sphere 02.12.0024r femoral component sphere cemented size 4+ r (k140826) lot 2114604: (b)(4) items manufactured and released on 02-dec-2021.Expiration date: 21-nov-2026.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.Gmk-sphere 02.12.0414fr tibial insert fixed sphere flex size 4/14 mm r (k121416) lot 180410: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 26-apr-2023.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.
Event or Problem Description
At about 2 years and 9 months after primary, the patient came in reporting instability and the cause is unknown.The surgeon revised all components to gmk-hinge components.The surgery was completed successfully.

• Common Device Name: GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R
• 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: 21364697
• Report Number: 3005180920-2025-00080
• Device Sequence Number: 20941945
• Product Code: JWH
• UDI-Device Identifier: 07630030819919
• UDI-Public: 07630030819919
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/12/2025

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 Model Number: 02.07.1204R
• Device Lot Number: 2111931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2022
• 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 Sex: Male