MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R; TIBIAL INSERT FLEX

Catalog Number	02.12.0411FR
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12-jun-2024 lot 2302932: (b)(4) items manufactured and released on 13-apr-2023.Expiration date: 2028-03-19.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.
Event or Problem Description
On the (b)(6) 2020 the patient underwent primary surgery.Subsequently, on the (b)(6) 2023, the patient has been revised because of infection (emdr 2023-00929).The surgeon performed a washout and revised successfully the liner.Presently, on the (b)(6) 2024, the patient came in reporting infection.A washout was performed and the liner was successfully revised.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R
• Common Device Name: TIBIAL INSERT FLEX
• 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: 19517490
• Report Number: 3005180920-2024-00446
• Device Sequence Number: 6171510
• Product Code: JWH
• UDI-Device Identifier: 07630030862625
• UDI-Public: 07630030862625
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 06/12/2024

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: 02.12.0411FR
• Device Lot Number: 2302932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2023
• 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