MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 6/12 MM R; TIBIAL INSERT FIXED FLEX

Model Number	02.12.0612FR
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020: lot 171908: 25 items manufactured and released on 12-jun-2017.Expiration date: 2022-05-25.No anomalies found related to the problem.To date, 5 items of the same lot have been sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs department: insert revision in tka 1 year and 10 months after primary for joint instability.The insert was exchanged to a thicker one.The developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.It is therefore common practice to resort to a thicker insert and recreate soft tissue tension.This is not a problem due to any implant defect or malfunction.
Event or Problem Description
The patient came in after 1 year and 10 months reporting instability, which was due to laxity.The surgeon revised the 12mm insert with a 14mm insert and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 6/12 MM R
• Common Device Name: TIBIAL INSERT FIXED FLEX
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11153446
• Report Number: 3005180920-2021-00029
• Device Sequence Number: 19669089
• Product Code: JWH
• UDI-Device Identifier: 07630030826986
• UDI-Public: 07630030826986
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2021

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: 05/25/2022
• Device Model Number: 02.12.0612FR
• Device Catalogue Number: 02.12.0612FR
• Device Lot Number: 171908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/12/2021
• 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
• Patient Age: 57 YR