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

Model Number	02.18.IF3.08.RM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/29/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2023-00006
• Device Sequence Number: 14118748
• Product Code: HSX
• UDI-Device Identifier: 07630030895982
• UDI-Public: 07630030895982
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2023

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: 09/07/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2022
• Initial Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2021
• 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: Required Intervention
• Patient Sex: Female