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

Model Number 02.18.TF4.RM

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 14-nov-2022.Lot 2207895: (b)(4) items manufactured and released on 20-jul-2022.Expiration date: 2027-07-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Comments: the r&d department received the feedback reported by the surgeon.A prototype was sent to the surgeon, and then, after a positive outcome, a dedicated instrument will be developed in order to have an easier phase of impaction and keel preparation.

Event Description

During impacting of the final implants, the tibia would not stay seated and kept lifting up.The tibia was removed, and all the cement as well.The surgeon reattempt the keel preparation and impacted the tibia again with a second fresh mix of cement but still the tibia would not seat fully and was lifting.For a second time, he had to take out the tibia and remove the cement from it and attempted a third preparation of the keel, but this time using just the keel guide and a narrow osteotome.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S4 RM
• Type of Device: UNICOMPARTIMENTAL KNEE TIBIAL TRAY CEMENTED
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15796859
• MDR Text Key: 304784688
• Report Number: 3005180920-2022-00851
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896767
• UDI-Public: 07630030896767
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2017
• Device Model Number: 02.18.TF4.RM
• Device Catalogue Number: 02.18.TF4.RM
• Device Lot Number: 2207895
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2022
• 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): Other
• Patient Sex: Male