MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 RM - 8MM

Model Number	02.18.IF5.08.RM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on november 3rd 2020: lot 167817: (b)(4) items manufactured and released on 03-jan-2017.Expiration date: 01-dec-2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Other devices involved in the event: moto partial knee 02.18.If5.08.Rm tibial insert fix s5 rm - 8mm lot.1900854 (k162084) batch review performed on november 3rd 2020.Lot 1900854: (b)(4) items manufactured and released on 25-jul-2019.Expiration date: 10-jul-2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Moto partial knee 02.18.Tf5.Rm tibial tray fix cemented s5 rm lot.1900841 (k162084) batch review performed on november 3rd 2020.Lot 1900841: (b)(4) items manufactured and released on 13-aug-2019.Expiration date: 23-jul-2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
During the primary knee surgery, when the surgeon went to snap the tibial insert fix s5 rm - 8mm into place, it would not lockdown.The agent retrieved a new 8 mm tibial insert, which also did not lock in or seat.The surgeon implanted the 2nd insert into the patient, however, it never locked into place.A third 8 mm liner was not available in the set.Bone and soft tissue were debriefed away and not interfering with the locking mechanism.The tibial rails were clear and the surgeon checked for bone and cement with none to be found.
Additional Manufacturer Narrative
Visual inspection of the uhmwpe insert the posterior feature of the insert, intended to be inserted in the dedicated seat of the baseplate, is damaged and plastically deformed.It presents a sort of incision with the negative shape of the edge of the correspondent feature of the baseplate, where the insert is supposed to be engaged.We can suppose that , in the first attempt to fix the insert into the baseplate, the insert was not posteriorly well positioned and not engaged in the baseplate.In this attempt, the insert was pushed posteriorly and was damaged.It was then not possible to snap the insert into the baseplate in the following attempts due to this deformation.It is not clear if the surgeon left inside the joint an insert that never locked into place or an insert that locked but without an audible 'click'.In the first scenario, that is out of label, a mobilization of the insert could occur.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 RM - 8MM
• Common Device Name: TIBIAL INSERT FIX
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10875419
• Report Number: 3005180920-2020-00815
• Device Sequence Number: 3316230
• Product Code: HSX
• UDI-Device Identifier: 07630030896224
• UDI-Public: 07630030896224
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: 12/01/2021
• Device Model Number: 02.18.IF5.08.RM
• Device Catalogue Number: 02.18.IF5.08.RM
• Device Lot Number: 167817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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: Other