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

Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Unspecified Tissue Injury (4559)

Event Date 03/31/2021

Event Type  Injury  

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 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
• Type of Device: TBIAL INSERT FIXED
• 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: 11752753
• MDR Text Key: 250868832
• Report Number: 3005180920-2021-00342
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896217
• UDI-Public: 07630030896217
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/03/2017
• 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): Required Intervention