MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0512FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R; KNEE TIBIAL INSERT

Catalog Number	02.12.0512FR
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery 10 days post primary due to infection.The surgeon performed a washout and revised the liner.The surgery was completed successfully.The pathogen is unknown.
Additional Manufacturer Narrative
Batch review performed on 05 july 2023: lot 189060: (b)(4) manufactured and released on 22-feb-2020.Expiration date: 2024-02-13.No anomalies found related to the problem.To date, 73 items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-SPHERE 02.12.0512FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R
• Common Device Name: KNEE TIBIAL INSERT
• 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: 17413797
• Report Number: 3005180920-2023-00553
• Device Sequence Number: 8902032
• Product Code: JWH
• UDI-Device Identifier: 07630030826788
• UDI-Public: 07630030826788
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• 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): 07/28/2023

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: 02/13/2024
• Device Catalogue Number: 02.12.0512FR
• Device Lot Number: 189060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2020
• 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: Unknown