MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.IF2.08.RM TIBIAL INSERT FIX S2 RM - 8MM; KNEE TIBIAL INSERT

Model Number	02.18.IF2.08.RM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 april 2022.Lot 2104796: (b)(4) items manufactured and released on 01-jul-2021.Expiration date: 2026-jun-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event (in this event, 2 devices are reported).Other device involved: batch review performed on 26 april 2022.Moto partial knee 02.18.Tf2.Rm tibial tray fix cemented s2 rm (k162084) lot 2013289: (b)(4) items manufactured and released on 18-mar-2021.Expiration date: 2026-mar-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Event or Problem Description
The two inserts couldn't be fixed to the tibial tray.The front lock part of the 1st and 2nd inserts deformed when the surgeon tried to insert them.A 3rd insert of another lot (ref:02.18.If2.08.Rm, lot:2115121) could be fixed and the surgery was completed successfully.Delay time is 30min and total time is 2hours 15min.Femur was already in place.This was is the 1st surgery with moto for the surgeon.
Additional Manufacturer Narrative
Visual inspection of the returned uhmwpe inserts performed by medacta knee r&d manager: the posterior feature of the insert intended to be engaged in the posterior dedicated seat of the baseplate, has been plastically deformed and damaged.It presents a sort of incision of the negative shape of the edge of the baseplate.This is visible on both the inserts object of the complaint.The anterior elastic lip of the inserts look damaged as well.We can suppose that , in the first attempt to fix each of the insert into the baseplate, the insert was not well seated and positioned in the baseplate.In these attempts the insert was pushed down and posteriorly and was permanently damaged both posteriorly and anteriorly, compromising the possibility to be engaged in the following attempts.

• Brand Name: MOTO PARTIAL KNEE 02.18.IF2.08.RM TIBIAL INSERT FIX S2 RM - 8MM
• Common Device Name: KNEE TIBIAL INSERT
• 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: 14374585
• Report Number: 3005180920-2022-00363
• Device Sequence Number: 1982916
• Product Code: HSX
• UDI-Device Identifier: 07630030895869
• UDI-Public: 07630030895869
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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: 06/16/2026
• Device Model Number: 02.18.IF2.08.RM
• Device Catalogue Number: 02.18.IF2.08.RM
• Device Lot Number: 2104796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian