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

Model Number	02.18.IF3.08.RM
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed due to pain after about 1 year from the primary surgery.Only the liner was replaced, thickness has not been changed, due to yellow bone and soft tissues discoloration.Suspect of infection but not confirmed.The liner was a little bit dented.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director.One year after uka in a heavy young patient, pain is reported and revision undertaken.All components look well fixed and well positioned.The report mentions tissue discoloration, so investigation for possible infections or local inflammatory processes has been undertaken.Only the insert is exchanged, to another of the same size and thickness.We cannot identify a mechanical cause for this unsuccessful result.No direct link with a product defect or malfunction can be established.Batch review performed on 20 april 2022.Lot 2009903: (b)(4).Expiration date: 2025-10-06.No anomalies found related to the problem.(b)(4).

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM
• Common Device Name: PARTIAL KNEE TIBIAL INSERT PE
• 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: 14158287
• Report Number: 3005180920-2022-00268
• Device Sequence Number: 19544485
• Product Code: HSX
• UDI-Device Identifier: 07630030895982
• UDI-Public: 07630030895982
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 04/20/2022

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: 10/06/2025
• Device Model Number: 02.18.IF3.08.RM
• Device Catalogue Number: 02.18.IF3.08.RM
• Device Lot Number: 2009903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2020
• 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 Age: 45 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Race: White