MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

Model Number	02.07.1205L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25-04-2025.Lot 2242046: (b)(4) items manufactured and released on 08-02-2023.Expiration date: 2028-01-25.No anomalies found related to the problem.To date, all item of the same lot has been sold with no similar reported event during the period of review.Additional device involved: batch review performed on 25-04-2025.Gmk-sphere 02.12.E0510fl tibial insert fixed sphere flex size 5/10 mm l e-cross (k202022) lot 2245474: (b)(4) items manufactured and released on 06-12-2023.Expiration date: 2023-02-06.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.The cause is an inadvertent oversight at the surgical center.There is no indication that any potential issue with the device may have caused or contributed to the event.Device production history and related documentation show no deviation from the process.
Event or Problem Description
Back on (b)(6) 2023, during the primary right knee surgery, the surgeon accidently implanted a left tibial tray and insert into the right knee.After closure, the surgeon opened the patient again, removed the tibial tray and insert and implanted right side tray and insert.The surgery was completed successfully.At about 1 month from the primary the patient developed an infection, and the liner was revised, mdr 3005180920-2023-00445 was filed.No further revisions were reported.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 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: 22058931
• Report Number: 3005180920-2025-00430
• Device Sequence Number: 15362250
• Product Code: JWH
• UDI-Device Identifier: 07630030819926
• UDI-Public: 07630030819926
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: 02.07.1205L
• Device Lot Number: 2242046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male