MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3I4 R; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.12.T3I4R
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 june 2024 lot 2008714: (b)(4) items manufactured and released on 01-feb-2021.Expiration date: 2026-01-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no other similar reported event during the period of review.Additional device involved batch review performed on 27 june 2024 gmk-sphere 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416) lot 2010145: (b)(4) items manufactured and released on 29-oct-2020.Expiration date: 2025-10-15.No anomalies found related to the problem.To date, all items of the same lot have been sold with another similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs manager: 3 years after revision tka, the patient feels instability on the lateral side.From the images received, we cannot assess the stability of the joint.It is very probable that a different orientation of the tibial component had become required, possibly because of secondary ligament laxity, particularly of lcl.We see no reason to suspect a faulty or malfunctioning device.
Event or Problem Description
Primary surgery performed on the (b)(6) 2021.Implantation of gmk-sphere implants (tibial tray t3i4 - tibial insert 4 10mm - femoral component 4 (02.12.0004r / 2010165) - resurfacing patella 3).On the (b)(6) 2022, revision surgery performed for patella loosening.Osteophyte removal and implantation of a new patella 3.On the (b)(6) 2024, the patient came in reporting pain.Revision surgery performed for knee instability on the lateral side and tibial tray loosening.No loosening of the femoral component.No infection.The surgeon revised the tibial tray, the insert (from 10 mm to 17 mm) and used an extension stem.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3I4 R
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• 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: 19814523
• Report Number: 3005180920-2024-00523
• Device Sequence Number: 8665892
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• 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: 2021
• 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): 07/24/2024

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: 01/19/2026
• Device Catalogue Number: 02.12.T3I4R
• Device Lot Number: 2008714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2021
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 86 KG