MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM

Model Number 02.18.IF3.08.RM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/29/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 03 january 2023: lot 2108470: (b)(4) items manufactured and released on 27-sept-2021.Expiration date: 2026-09-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

Event Description

The patient came in for a post-op appointment and it was observed that patient's femoral component would impinge upon cement in flexion.At about 8 months post primary the surgeon removed the poly, cleared out cement posteriorly and put in a new poly successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM
• Type of Device: PARTIAL KNEE TIBIAL INSERT
• 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: 16181553
• MDR Text Key: 307495068
• Report Number: 3005180920-2023-00006
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895982
• UDI-Public: 07630030895982
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.18.IF3.08.RM
• Device Catalogue Number: 02.18.IF3.08.RM
• Device Lot Number: 2108470
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2021
• 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
• Patient Sex: Female