MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0512FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R; KNEE TIBIAL INSERT FIXED SPHERE FLEX

Catalog Number	02.12.0512FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 january 2023.Lot 2005772: (b)(4) items manufactured and released on 16-sep-2020.Expiration date: 2025-sep-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event during the period of review.
Event or Problem Description
About 6 months and a half after the primary surgery, the patient came in for a post-op appointment and it was observed by the surgeon that the patient's knee was unstable.After further discussion, it was concluded that a custom size poly implant is needed for the patient (gmk-sphere tibial insert with a 14mm mid-compartment thickness and 11mm lateral thickness).Revision will be performed.

• Brand Name: GMK-SPHERE 02.12.0512FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R
• Common Device Name: KNEE TIBIAL INSERT FIXED SPHERE FLEX
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18657577
• Report Number: 3005180920-2024-00034
• Device Sequence Number: 15252661
• Product Code: JWH
• UDI-Device Identifier: 07630030826788
• UDI-Public: 07630030826788
• 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: 2023
• 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): 02/07/2024

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: 09/03/2025
• Device Catalogue Number: 02.12.0512FR
• Device Lot Number: 2005772
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 02/07/2024
• 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: Male