MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL TRAY FIX CEMENTED S.5L; KNEE TIBIAL TRAY CEMENTED

Model Number	02.07.1205L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 may 2023: lot 2109876: (b)(4) items manufactured and released on 10-nov-2021.Expiration date: 2026-10-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs department: 1.5 years after primary cemented tka, the tibial tray is mobilized and needs replacement.The images supplied shows a very pronounced tibial slope, and possibly an insufficient coverage of the posterior aspect of the tibial bone.These may be contributing factors to an abnormal stress of the metal/cement/bone interface, and it's possible that it may result in loosening.No reason to suspect a faulty device.Preliminary investigation performed by r&d project manager: revision surgery of a gmk sphere implant after 1 year and a half from primary implantation for tibial loosening.From the picture of the explanted tibial baseplate sent for investigation, no anomalies can be noted on the component.We can't see any evidences that the event is related to a faulty device.
Event or Problem Description
Revision surgery for cemented tibial tray loosening 1 year and 4 months post primary.All components were revised successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: revision surgery of a gmk sphere implant after 1 year and a half from primary due to tibia loosening.From visual investigation on the returned explanted components, no residual cement can be noted on the distal surface of tibial baseplate.On the articular surfaces of the tibial insert, no signs of wear or delamination can be noted.No anomalies can be noted on the femoral component.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).From visual inspection, there is no evidence to suspect that the event is related to a faulty device.Additional information reported: data of return of the piece: 23 june 2023.Visual inspection of the device.

• Brand Name: GMK-PRIMARY TIBIAL TRAY FIX CEMENTED S.5L
• Common Device Name: KNEE TIBIAL TRAY CEMENTED
• 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: 17190245
• Report Number: 3005180920-2023-00439
• Device Sequence Number: 20285372
• Product Code: JWH
• UDI-Device Identifier: 07630030819926
• UDI-Public: 07630030819926
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090988
• 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): 07/21/2023

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 Model Number: 02.07.1205L
• Device Catalogue Number: 02.07.1205L
• Device Lot Number: 2109876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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: 83 YR
• Patient Sex: Male