MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-PRIMARY PATELLA RESURFACING SIZE 3

Model Number	02.07.0035RP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation: mobilization of the prosthetic patella 1.5 years after cemented tka.The all-pe patella was found with fractures in the pe pegs.The radiographs show that the patella is markedly external to the trochlea in flexion, and this condition carries significant shear loads to the implant-bone interface.It is conceivable that a problem arose during cementation: normally, the cement mantle should adhere to the pe surface and take the shear stresses, although the rotational problem of this case may have nonetheless generated some discomfort to the patient.The fracture of the pe pegs should not be considered the cause for the need of a revision surgery: the position of the patella was suboptimal and the main cause for patella mobilization should probably be sought in a cement problem.If the cement mantle is not mechanically viable, the pe pegs cannot be expected to withstand the shear stresses of an implant with such marked alignment problems.Analysis performed by r&d manager: the primary issue leading to patellar mobilization was likely a cementation problem rather than the fracture of the polyethylene pegs.Since the cement mantle is supposed to bear shear stresses and ensure proper adhesion, a failure in this process could have led to loosening.The lateral malposition of the patella further suggests excessive shear forces at the bone-implant interface, contributing to failure.Even though the broken pegs were observed, they were likely a consequence rather than the root cause of failure.Based on the available information, it is possible to conclude that the failure is not related to a faulty device.Batch review performed on 18 february 2025.Lot 2313855: (b)(4) items manufactured and released on 28-sep-2023.Expiration date: 2028-09-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.It is likely that the event was triggered by sub-optimal patella position combined with a cementation issue.The investigation does not indicate a potential manufacturing related issue or systemic deficiency.
Event or Problem Description
Revision surgery due to patella resurfacing mobilization, at about 1 year 3 months after primary.During the revision, the patellar implant was found with 3 broken pegs still in the bone.Patellar implant successfully revised.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-PRIMARY PATELLA RESURFACING SIZE 3
• 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: 21523852
• Report Number: 3005180920-2025-00163
• Device Sequence Number: 12846981
• Product Code: JWH
• UDI-Device Identifier: 07630030815768
• UDI-Public: 07630030815768
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 03/05/2025

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: 02.07.0035RP
• Device Lot Number: 2313855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2023
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 100 KG