MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0311CRR TIBIAL INSERT FIXED SPHERE CR SIZE 3/11 MM R; KNEE TIBIAL INSERT FIXED

Model Number	02.12.0311CRR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting difficulty with flexion mobility and the cause is unknown.About 1 year and 4 months after the primary surgery, the surgeon released the pcl and revised the insert (from 11 to 10 mm).The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 2 november 2022: lot 2008258: (b)(4) items manufactured and released on 16-sep-2020.Expiration date: 2025-sep-01.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.

• Brand Name: GMK-SPHERE 02.12.0311CRR TIBIAL INSERT FIXED SPHERE CR SIZE 3/11 MM R
• Common Device Name: KNEE TIBIAL INSERT FIXED
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15864348
• Report Number: 3005180920-2022-00862
• Device Sequence Number: 5994149
• Product Code: JWH
• UDI-Device Identifier: 07630040707367
• UDI-Public: 07630040707367
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 11/25/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2025
• Device Model Number: 02.12.0311CRR
• Device Catalogue Number: 02.12.0311CRR
• Device Lot Number: 2008258
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2020
• 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: Female