MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM; KNEE CEMENTED FEMORAL COMPONENT

Catalog Number	02.18.004LM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18-jul-2023: lot 2004504: (b)(4) items manufactured and released on 22-jul-2020.Expiration date: 2025-07-14.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional involved implant: batch review performed on 18-jul-2023 on moto partial knee 02.18.Tf5.Lm tibial tray fix cemented s5 lm (k162084) lot.1902961 lot 1902961: (b)(4) items manufactured and released on 27-aug-2019.Expiration date: 2024-07-28.No anomalies found related to the problem.To date, all items of the same lot have been sold with another similar reported event during the period of review.
Event or Problem Description
At about 2 years and 4 months from the primary, the patient came in reporting pain due to loose components and the cause is unknown.The surgeon converted the patient from a moto partial knee to a sphere knee.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• 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: 17395200
• Report Number: 3005180920-2023-00600
• Device Sequence Number: 20313891
• Product Code: HSX
• UDI-Device Identifier: 07630030895593
• UDI-Public: 07630030895593
• 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: 2021
• 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): 07/26/2023

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 Expiration Date: 07/14/2025
• Device Catalogue Number: 02.18.004LM
• Device Lot Number: 2004504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2020
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White