MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L

Model Number	02.12.0312FL
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 september 2020: lot 146602: (b)(4) items manufactured and released on 26-nov-2014.Expiration date: 2019-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Visual inspection performed by r&d knee manager: revision surgery of a gmk sphere tibial insert after 5 years from primary implantation due to instability.A 12mm insert has been replaced with a 17mm.From visual inspection of the explanted component, the articular surface of the insert looks worn out on the very posterior part of the lateral condyle, on the posterior edge of the insert.The insert is not worn in the anterior and central portion of the lateral condyle.This is an evidence that the femur was articulating with the tibia in its posterior portion during daily life activities, from extension to mid-flexion where the femur is expected to articulate in a more anterior portion of the condyle.With the available information, it is not possible to assess if this was related to a malposition of the tibia component during primary surgery or to a progressive degenerative condition of the patient (i.E.Soft tissue laxities).
Event or Problem Description
Instability of a knee prosthesis implanted in 2015.Ligamentous condition was very critical, liner 12mm has been revised with a 17mm one 4 years and 11 months after primary.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs director: 5 years after primary cemented tka ligamentous instability demands further surgery.The insert is replaced with a thicker one.The previous insert is found to be worn, which may be caused by instability.No reason to suspect that a device defect caused the revision surgery.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10619433
• Report Number: 3005180920-2020-00668
• Device Sequence Number: 14386406
• Product Code: JWH
• UDI-Device Identifier: 07630030826375
• UDI-Public: 07630030826375
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2020

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: 10/31/2019
• Device Model Number: 02.12.0312FL
• Device Catalogue Number: 02.12.0312FL
• Device Lot Number: 146602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 11/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75