MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.TF5.RM TIBIAL TRAY FIX CEMENTED S5 RM; KNEE TIBIAL TRAY

Catalog Number	02.18.TF5.RM
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: tibial plateau fracture occurred 1 month after primary unicompartmental knee arthroplasty.Bone weakening during normal intraoperative tibial preparation and sudden movements may have favoured the formation of the fracture.Batch review performed on 21 february 2019: lot 170796: (b)(4) items manufactured and released on 27-jun-2017.Expiration date: 2022-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, 1 month and a half after primary surgery, complaining of post operative pain that was getting worse over time.The cause of the pain was a fractured tibia and the surgeon suspects the fracture occured during the primary surgery when he inserted the trial baseplate.The surgeon used another company's plate and screws to fix the fracture and also revised the tibial insert.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE 02.18.TF5.RM TIBIAL TRAY FIX CEMENTED S5 RM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8361562
• Report Number: 3005180920-2019-00083
• Device Sequence Number: 19311464
• Product Code: HSX
• UDI-Device Identifier: 07630030896781
• UDI-Public: 07630030896781
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 06/07/2022
• Device Catalogue Number: 02.18.TF5.RM
• Device Lot Number: 170796
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention