MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM; CEMENTED PARTIAL TIBIAL TRAY

Model Number	02.18.TF5.LM
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 april 2022.Lot 2103557: (b)(4) items manufactured and released on 27-may-2021.Expiration date: 2026-05-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director.Few weeks after primary unicompartmental arthroplasty a fracture occurs and the surgeon decides to convert to a total knee.The radiographs attached are of very low quality and no evaluation is possible.There is no mention of a traumatic event.The bone fracture must have been caused either by a trauma or by the inevitable weakening of the bone consequent to the surgical procedure.In either case, we see no reason to suspect that a defective device is at the root of this adverse event.
Event or Problem Description
At about 1 month and half after the primary, the patient came in reporting pain due to a fractured tibia and the cause is unknown.The surgeon converted the patient from a moto to sphere.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM
• Common Device Name: CEMENTED PARTIAL TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14485682
• Report Number: 3005180920-2022-00395
• Device Sequence Number: 12092583
• Product Code: HSX
• UDI-Device Identifier: 07630030896774
• UDI-Public: 07630030896774
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 05/24/2022

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: 05/11/2026
• Device Model Number: 02.18.TF5.LM
• Device Catalogue Number: 02.18.TF5.LM
• Device Lot Number: 2103557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2021
• 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 Sex: Male