MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L E-CROSS; KNEE TIBIAL INSERT

Model Number	02.12.E0210FL
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient came in reporting pain due to anterior dislocation of the poly from the tibial tray, which occurred when the patient was getting up from a seated position.The surgeon revised the femoral component, tibial tray, and poly 2 days after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06 may 2022: lot 2105592: (b)(4) items manufactured and released on 06-jul-2021.Expiration date: 2026-06-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional device involved: batch review performed on 06 may 2022: lot 2114746: (b)(4) items manufactured and released on 24-jan-2022.Expiration date: 2027-01-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L E-CROSS
• Common Device Name: KNEE 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: 14521358
• Report Number: 3005180920-2022-00419
• Device Sequence Number: 20073952
• Product Code: JWH
• UDI-Device Identifier: 07630971261273
• UDI-Public: 07630971261273
• 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: 2022
• Device Explanted Year: 2022
• 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): 05/27/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2026
• Device Model Number: 02.12.E0210FL
• Device Catalogue Number: 02.12.E0210FL
• Device Lot Number: 2105592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2021
• 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 Sex: Female