MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R; KNEE TIBIAL TRAY FIXED CEMENTED

Catalog Number	02.07.1202R
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month after the primary, the patient came in reporting pain and discomfort and the cause is unknown.The surgeon revised the femur, insert and tibial tray with revision components.The surgery was completed successfully.Any issue with the implants detected.
Additional Manufacturer Narrative
Batch review performed on 01-sep-2023.Lot 2119173: (b)(4) items manufactured and released on 26-apr-2022.Expiration date: 2027-04-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other devices involved: gmk-sphere 02.12.0021r femoral component sphere cemented size 1+ r (k140826) lot 2103456: (b)(4) items manufactured and released on 08-jun-2021.Expiration date: 2026-05-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Gmk-sphere 02.12.E0212fr tibial insert fixed sphere flex size 2/12 mm r e-cross (k202022) lot 2105597: (b)(4) items manufactured and released on 06-jul-2021.Expiration date: 2026-06-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R
• Common Device Name: KNEE TIBIAL TRAY FIXED CEMENTED
• 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: 17823868
• Report Number: 3005180920-2023-00742
• Device Sequence Number: 6205593
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2023

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 Catalogue Number: 02.07.1202R
• Device Lot Number: 2119173
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2022
• 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: Female