MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 11MM; KNEE TIBIAL INSERT

Catalog Number	02.12.E0411FL
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 2 weeks for infection the pathogen is unknown.The surgeon performed a washout and revised the liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 11 july 2023: lot 2247372: (b)(4) manufactured and released on 10-feb-2023.Expiration date: 2028-01-26.No anomalies found related to the problem.To date, 9 items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-SPHERE GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 11MM
• 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: 17413824
• Report Number: 3005180920-2023-00574
• Device Sequence Number: 15709578
• Product Code: JWH
• UDI-Device Identifier: 07630971261792
• UDI-Public: 07630971261792
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• 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): 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 Catalogue Number: 02.12.E0411FL
• Device Lot Number: 2247372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2023
• 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