MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM

Catalog Number	02.18.IF4.08.LM
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 october 2023 lot 2219899: (b)(4) items manufactured and released on 10-oct-2022.Expiration date: 2027-09-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 17 october 2023.Moto partial knee 02.18.If4.08.Llrl tibial insert fix s4 - lateral - 8mm (k183029) lot 2215654: 16 items manufactured and released on 10-oct-2022.Expiration date: 2027-09-22.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs manager on the (b)(6) 2023: a reoperation was conducted 1 year after the primary implant of a bi-monocompartmental knee arthroplasty (moto medial and moto lateral).The reported casuse is a purulent arthritis, for which a scraping procedure was conducted.Infection is a possible complication of knee surgery and a delayed onset (such in this case) is widely described in the literature.On the available x-rays, there are doubtful signs of bony alteration in the proximal tibia (especially on the lateral side).However the surgeon evaluated the implant stable, changing only the inserts.We have no reason to suspect a defective or malfunctioning device.
Event or Problem Description
At about 11 months after the primary, revision surgery was performed due to suspected infection.At the time of purulent arthritis scraping, both inserts (moto medial-lateral) were successfully replaced.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM
• Common Device Name: 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18011664
• Report Number: 3005180920-2023-00840
• Device Sequence Number: 12591324
• Product Code: HSX
• UDI-Device Identifier: 07630030896095
• UDI-Public: 07630030896095
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 10/26/2023

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 Catalogue Number: 02.18.IF4.08.LM
• Device Lot Number: 2219899
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2022
• 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: 81 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian