MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM R; KNEE TIBIAL INSERT

Catalog Number	02.12.0214FR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient has undergone a uka in 2012 with competitor components.On the(b)(6) 2022, the patient has been revised because of a fall which had partially affected the internal lateral ligament and the stability of the prosthesis.Implantation of gmk-sphere components with myknee cutting guides.On the (b)(6) 2024, the patient has been revised due to instability of the knee without loosening of the implants.Complete rupture of the internal lateral ligament was detected.The patient did not mention a fall.No infection.The surgeon revised the tibial insert (14mm) with a thicker one (17mm) and a suture of the internal lateral ligament has been performed.The surgery has been completed successfully.
Additional Manufacturer Narrative
Batch review performed on 26-jun-2024: lot 2118435: (b)(4) items manufactured and released on 23-feb-2022.Expiration date:2027-02-02.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 2/14 MM R
• Common Device Name: KNEE TIBIAL INSERT
• 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: 19728254
• Report Number: 3005180920-2024-00517
• Device Sequence Number: 18150944
• Product Code: JWH
• UDI-Device Identifier: 07630030826221
• UDI-Public: 07630030826221
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 07/12/2024

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 Catalogue Number: 02.12.0214FR
• Device Lot Number: 2118435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2022
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 75 KG