MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R

Model Number	02.12.0211FR
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 february 2021: lot 1900393: (b)(4) items manufactured and released on 30-apr-2019.Expiration date: 2024-04-14.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.Clinical evaluation performed by medical affairs director: one year after tka the patient laments knee instability.This is assessed to be due to ligament laxity, intervened over time.The cause of this adverse event is disease progression and not a defect of the implanted device.A thicker insert solved the problem.
Event or Problem Description
The patient came in reporting instability due to laxity that occurred over time.The surgeon revised the sphere insert flex right 11mm s2 with a sphere insert flex right 13mm s2 1 year and 2 months after primary, to give the patient more stability.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11398441
• Report Number: 3005180920-2021-00152
• Device Sequence Number: 17285163
• Product Code: JWH
• UDI-Device Identifier: 07630030862540
• UDI-Public: 07630030862540
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

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: 04/14/2024
• Device Model Number: 02.12.0211FR
• Device Catalogue Number: 02.12.0211FR
• Device Lot Number: 1900393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 03/02/2021
• 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