MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L

Model Number	02.12.0311FL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16.03.2021: lot 2000393: (b)(4) items manufactured and released on 12-mar-2020.Expiration date: 2025-02-22.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.
Event or Problem Description
Revision surgery performed due to knee instability.
Additional Manufacturer Narrative
Xrays analysis performed on (b)(6) 2021.Also, event description has been updated.Clinical evaluation performed by medical affairs manager insert revision in tka 5 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
Revision surgery has been performed due to knee instability after 5 months and 18 days after the primary surgery.The surgeon revised the liner from 11mm to 17mm.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 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: 11594050
• Report Number: 3005180920-2021-00252
• Device Sequence Number: 19701499
• Product Code: JWH
• UDI-Device Identifier: 07630030862564
• UDI-Public: 07630030862564
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 05/26/2021

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: 02/22/2025
• Device Model Number: 02.12.0311FL
• Device Catalogue Number: 02.12.0311FL
• Device Lot Number: 2000393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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: 64 YR