MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0514FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L; KNEE TIBIAL INSERT FIXED

Catalog Number	02.12.0514FL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 december 2023 lot 1910695: 50 items manufactured and released on 05-feb-2020.Expiration date: 2025-01-19.No anomalies found related to the problem.To date, 26 items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot 2012650: 98 items manufactured and released on 09-apr-2021.Expiration date: 2026-03-23.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision surgery due to pain at 1 year and 3 months from the primary.The reason of the pain is unknown.Gmk-sphere with extension stem implanted.
Additional Manufacturer Narrative
Clinical evaluation performed by clinical affairs department.About one year after primary cemented tka, the tibial component is revised due to pain.Looking at the radiographs, it appears as if the tibial cut had been damaged, because it looks like a lump of cement is present below the tray in the medial region.Both components may be slightly undersized.Radiolucent lines are visible along the femoral implant, but according to report this was not exchanged.We see no reason to suspect a faulty implant at the origin of this adverse event.

• Brand Name: GMK-SPHERE 02.12.0514FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L
• Common Device Name: KNEE TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18382650
• Report Number: 3005180920-2023-01016
• Device Sequence Number: 7797290
• Product Code: JWH
• UDI-Device Identifier: 07630030826818
• UDI-Public: 07630030826818
• 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: 2022
• Device Explanted Year: 2023
• 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): 01/24/2024

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: 01/19/2025
• Device Catalogue Number: 02.12.0514FL
• Device Lot Number: 1910695
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2020
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White