MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.07.1202L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 aug 2024.Lot 189124: (b)(4) items manufactured and released on 07-feb-2019.Expiration date: 2024-01-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department.5 years after primary cemented tka, the tibial tray requires revision because of progressive subsidence in the posterior aspect.This is most likely due to bone subsidence, possibly related to insufficient coverage or more likely to progressive bone resorption - the image provided is not sufficient to determine a possible cause.No reason to suspect a faulty device.
Event or Problem Description
At 4 years and 11 months from the primary, revision surgery due to posterior tibial tray subsidence.No reported problems with the contralateral side.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.Revision surgery of a gmk sphere implant after around 5 years from primary implantation due to tibia subsidence.From visual inspection of the explanted components, we can't identify any anomalies relevant to the event.The medial posterior side of the tibial insert looks lightly worn out only, as expected after 5 years of implantation.We can note also the color of the tibial insert turned yellow in some portions.This is something that affects only the external surfaces of the insert and is not related to abnormal oxidation of the liner.No traces of residual cement can be observed on the distal plane of the tibial tray.The absence or lack of cement on explanted components it's something that can be observed in returned devices object of complaint, it's not a predictor of faulty devices.The present event is most likely due to bone subsidence, possibly related to insufficient coverage or more likely to progressive bone resorption.From visual inspection, there is no evidence to suspect that the event is related to a faulty device.Information reported in this follow up 1: piece returned on 26 sept 2024.Visual inspection.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• 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: 20198556
• Report Number: 3005180920-2024-00704
• Device Sequence Number: 15330194
• Product Code: JWH
• UDI-Device Identifier: 07630030819865
• UDI-Public: 07630030819865
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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): 10/25/2024

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: 01/27/2024
• Device Catalogue Number: 02.07.1202L
• Device Lot Number: 189124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2019
• 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 Sex: Unknown
• Patient Race: Asian