MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0513FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R; KNEE TIBIAL INSERT FIXED

Catalog Number	02.12.0513FR
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.About 1 month after the primary surgery, the surgeon performed a washout and revised the liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 15 november 2023 lot 2103941: (b)(4) manufactured and released on 27-apr-2021.Expiration date: 2026-apr-13.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE 02.12.0513FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R
• Common Device Name: KNEE TIBIAL INSERT FIXED
• 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: 18272864
• Report Number: 3005180920-2023-00944
• Device Sequence Number: 4007200
• Product Code: JWH
• UDI-Device Identifier: 07630030862670
• UDI-Public: 07630030862670
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

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 Expiration Date: 04/13/2026
• Device Catalogue Number: 02.12.0513FR
• Device Lot Number: 2103941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2021
• 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: 58 YR
• Patient Sex: Male