MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L; FIXED TIBIAL INSERT

Model Number	02.12.0311FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 5 years 4 months after the primary the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2021.Lot 157017: (b)(4) items manufactured and released on 04-april-2016.Expiration date: 2021-03-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12851080
• Report Number: 3005180920-2021-00905
• Device Sequence Number: 4788183
• Product Code: JWH
• UDI-Device Identifier: 07630030862564
• UDI-Public: 07630030862564
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• 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): 11/22/2021

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: 03/10/2021
• Device Model Number: 02.12.0311FL
• Device Catalogue Number: 02.12.0311FL
• Device Lot Number: 157017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2016
• 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