MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED CR SIZE 5/13 MM L; FIXED TIBIAL INSERT

Model Number	02.12.0513CRL
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the insert with a higher one, 7 months after the primary surgery.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 25 october 2021: lot 188586: (b)(4) items manufactured and released on 30-jan-2019.Expiration date: 2024-jan-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED CR SIZE 5/13 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: 12818459
• Report Number: 3005180920-2021-00883
• Device Sequence Number: 11979328
• Product Code: JWH
• UDI-Device Identifier: 07630040707671
• UDI-Public: 07630040707671
• 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: 2021
• 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): 11/16/2021

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: 01/16/2024
• Device Model Number: 02.12.0513CRL
• Device Catalogue Number: 02.12.0513CRL
• Device Lot Number: 188586
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2019
• 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