MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S4 LM; TIBIAL TRAY PARTIAL KNEE SYSTEM

Catalog Number	02.18.TF4.LM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon noticed a tibial fracture in the post-primary x-rays.At 14 days after primary the surgeon revised all the moto devices and implanted a gmk-sphere with augment successfully.
Additional Manufacturer Narrative
Batch review performed on 25 october 2023: lot 2212249: (b)(4) items manufactured and released on 31-aug-2022.Expiration date: 2027-08-17.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 postoperative tibial fracture was reported a few days after primary cemented uka (moto partial knee system).No information about the cause of the fracture are reported.We cannot say whether a traumatic event occured or the quality of the bone was poor.However, the tibial preparation may have weakened the bone.The x-ray images show a depression fracture of the medial tibial plateu not involving the implant which appears well positioned.The patient was revised with a sphere total knee implant and an augment.With the element at disposal, there is no reason to suspect a faulty device.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S4 LM
• Common Device Name: TIBIAL TRAY PARTIAL KNEE SYSTEM
• 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: 18157959
• Report Number: 3005180920-2023-00884
• Device Sequence Number: 12760413
• Product Code: HSX
• UDI-Device Identifier: 07630030896750
• UDI-Public: 07630030896750
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 11/17/2023

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 Catalogue Number: 02.18.TF4.LM
• Device Lot Number: 2212249
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2022
• 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