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
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2022-00851
• Device Sequence Number: 4546310
• Product Code: HSX
• UDI-Device Identifier: 07630030896767
• UDI-Public: 07630030896767
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2022
• 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: Other
• Patient Sex: Male