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

Model Number	02.18.IF5.08.LM
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 20 days after the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and poly swap and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10 march 2023 lot 2013314: (b)(4) manufactured and released on 25-march-2021.Expiration date: 2026-03-02.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 8MM
• Common Device Name: KNEE TIBIAL INSERT FIX
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16635898
• Report Number: 3005180920-2023-00205
• Device Sequence Number: 17929593
• Product Code: HSX
• UDI-Device Identifier: 07630030896217
• UDI-Public: 07630030896217
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 03/29/2023

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: 03/02/2026
• Device Model Number: 02.18.IF5.08.LM
• Device Catalogue Number: 02.18.IF5.08.LM
• Device Lot Number: 2013314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• 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: Male