MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM

Model Number	02.12.0310FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18-oct-2022: lot 1910682: (b)(4) items manufactured and released on 05-feb-2020.Expiration date: 2025-01-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs director: 2 years after primary tka in a 75 year old woman, patella pain and lack of stability lead to revision surgery.This was likely due to disease progression, both for the secondary instability, normally due to ligament relaxation, and for the patellar pain, probably due to arthrosis of the patellar bone.No reason to suspect a faulty device at the origin of this revision.
Event or Problem Description
Revision surgery performed due to pain and laxity about 2 years after the primary surgery.Patella bone resurfaced and inlay changed with a thicker one (from 10 to 12 mm).

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM
• 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: 15666143
• Report Number: 3005180920-2022-00793
• Device Sequence Number: 19535407
• Product Code: JWH
• UDI-Device Identifier: 07630030826337
• UDI-Public: 07630030826337
• 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: 2020
• Device Explanted Year: 2022
• 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): 10/25/2022

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: 01/08/2025
• Device Model Number: 02.12.0310FL
• Device Catalogue Number: 02.12.0310FL
• Device Lot Number: 1910682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2020
• 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 Age: 75 YR
• Patient Sex: Female