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

Catalog Number	02.07.1202R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 years and 2 months from the primary, the patient came in reporting pain due to a loose tibial component.The cause of the loose tibial component is unknown.The surgeon revised the tibial tray, insert, and femur to competitor components.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 march 2024.Lot 2005035: (b)(4) items manufactured and released on 10-sept-2020.Expiration date: 2025-09-01.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.Investigation performed by r&d project manager.Revision surgery of a gmk sphere implant after 3 years from primary due to tibia loosening.From investigation based on the pictures of the removed components, no residual cement can be noted on the distal surface of tibial baseplate.Residual cement still adherent to the component is visible on the internal surface of the femoral implant.Poor interdigitation between cement and implant can be related to multiple factors, most likely not implant related (such as cementation process, temperature, time, presence of fluids on the surfaces of cement interface).Absence of cement is not an evidence of a faulty device.There is no evidence to suspect that the event is related to a faulty device.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R
• Common Device Name: KNEE TIBIAL TRAY CMENTED
• 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: 19069663
• Report Number: 3005180920-2024-00181
• Device Sequence Number: 6900743
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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 Catalogue Number: 02.07.1202R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2020
• 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 Sex: Unknown