MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MM; TBIAL INSERT FIXED

Model Number	02.18.IF5.08.LM
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Tissue Injury (4559)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 april 2021: lot 167811: (b)(4) items manufactured and released on 03-jan-2017.Expiration date: 2021-11-29.No anomalies found related to the problem.To date, 58 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in for a post-op appointment and the surgeon observed that the patient was in excessive valgus and wanted to increase the inset thickness to push the knee into a more neutral position.The surgeon revised the 8mm tibial insert with a 10mm one 2 years and 9 months after primary.The surgery was completed successfully.Note that the patient did not report pain or instability.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MM
• Common Device Name: TBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11752753
• Report Number: 3005180920-2021-00342
• Device Sequence Number: 19692687
• Product Code: HSX
• UDI-Device Identifier: 07630030896217
• UDI-Public: 07630030896217
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 04/30/2021

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: 11/29/2021
• Device Model Number: 02.18.IF5.08.LM
• Device Catalogue Number: 02.18.IF5.08.LM
• Device Lot Number: 167811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/30/2021
• 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: Required Intervention