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

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/27/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 292471331
• Report Number: 3005180920-2022-00395
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896774
• UDI-Public: 07630030896774
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.18.TF5.LM
• Device Catalogue Number: 02.18.TF5.LM
• Device Lot Number: 2103557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male