MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0110FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/10 MM L

Model Number	02.12.0110FL
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 march 2022.Lot 2002703: (b)(4) items manufactured and released on 05-may-2020.Expiration date: 2025-apr-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by medical affairs director: 1 year after primary cemented tka, instability is developed and a thicker insert is implanted in place of the original one.Secondary instability is a possible unfavourable evolution of tka, generally due to secondary ligament laxity.In this case, also secondary resurfacing of patella is undertaken, and this is also a frequent evolution of the arthritic knee, disease progression.This revision should not be ascribed to a faulty device.
Event or Problem Description
The patient had a feeling of knee pain and instability.About 1 year after the primary surgery, the surgeon decided to change to a thicker inlay and also resurface the patella.

• Brand Name: GMK-SPHERE 02.12.0110FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/10 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14167125
• Report Number: 3005180920-2022-00277
• Device Sequence Number: 14888510
• Product Code: JWH
• UDI-Device Identifier: 07630030825934
• UDI-Public: 07630030825934
• 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: 2022
• 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): 04/21/2022

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: 04/19/2025
• Device Model Number: 02.12.0110FL
• Device Catalogue Number: 02.12.0110FL
• Device Lot Number: 2002703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2020
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White