MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R; KNEE TIBIAL INSERT

Catalog Number	02.12.0410FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years and 8 months after primary, the patient has been revised because of patello-femoral dissatisfaction since after primary surgery.The cause of this dissatisfaction is unknown.The surgeon resurfaced successfully the patella bone and revised the insert (10mm) with a thicker one (11mm) to give the patient more stability.
Additional Manufacturer Narrative
Batch review performed on 20-jun-2024.Lot 2106569: (b)(4) items manufactured and released on 03-aug-2021.Expiration date: 2026-07-19.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.Clinical evaluation.About 2.5 years after primary tka, with no patella resurfacing, the patient complains of dissatisfaction at the patello femoral joint (not treated before) and the surgeon decides to replace the patellar surface as well.During the process, the tibial insert is exchanged, as customary procedure even in absence of problems, and an insert 1 mm thicker was used, to recuperate some ligament tension that, as often happens, was progressively lost after primary tka.No defects of the implants should be suspected.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 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: 19666931
• Report Number: 3005180920-2024-00505
• Device Sequence Number: 15109260
• Product Code: JWH
• UDI-Device Identifier: 07630030826542
• UDI-Public: 07630030826542
• 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): 07/03/2024

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: 07/19/2026
• Device Catalogue Number: 02.12.0410FR
• Device Lot Number: 2106569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2021
• 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: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White