MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R

Model Number	02.12.0212FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting instability and the cause is unknown.At about 1 year and 5 months, the surgeon revised the insert with a higher one (from 12 to 13 mm), and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22 september 2022 lot#: 2000428, 60 items manufactured and released on 13-mar-2020.Expiration date: 2025-feb-25.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 TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R
• Common Device Name: 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: 15575843
• Report Number: 3005180920-2022-00771
• Device Sequence Number: 19528400
• Product Code: JWH
• UDI-Device Identifier: 07630030826184
• UDI-Public: 07630030826184
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

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: 02/25/2025
• Device Model Number: 02.12.0212FR
• Device Catalogue Number: 02.12.0212FR
• Device Lot Number: 2000428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2020
• 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