MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L; KNEE TIBIAL INSERT FIXED

Model Number	02.12.0212FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 january 2023.Lot 2002712: (b)(4) items manufactured and released on 03-july-2020.Expiration date: 2025-06-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: a little over 1 year after primary cemented tka, reintervention is deemed advisable to stabilize the joint by changing the insert thickness.This is normally due to secondary relaxation of the ligaments, and it's not due to a malfunctioning device.At the same time, the surgeon decided also to resurface the patellar bone, which had not been treated in the previous surgery: this action was most probably dictated by disease progression.
Event or Problem Description
At about 1 year 2 months after the primary, revision surgery following laxity of the left knee.No infection.No loosening of the implants.No pain described by the patient.The surgeon revised successfully the liner (12mm to 17mm) and resurfaced the natural patella.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L
• Common Device Name: KNEE 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: 16378504
• Report Number: 3005180920-2023-00058
• Device Sequence Number: 6201661
• Product Code: JWH
• UDI-Device Identifier: 07630030826177
• UDI-Public: 07630030826177
• 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: 2023
• 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): 02/15/2023

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: 06/21/2025
• Device Model Number: 02.12.0212FL
• Device Catalogue Number: 02.12.0212FL
• Device Lot Number: 2002712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2020
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 70 KG