MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM; KBEE PARTIAL KNEE SZSTEM CEMENTED FEMORAL COMPONENT

Catalog Number	02.18.003RM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 may 2024 lot 2001410: (b)(4) items manufactured and released on 17-jun-2020.Expiration date: 2025-06-02.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Additional implants involved.Batch review performed on 24 may 2024 on moto partial knee 02.18.If4.10.Rm tibial insert fix s4 rm - 10mm (k162084) lot.172314.Lot 172314: (b)(4) items manufactured and released on 23-oct-2017.Expiration date: 2022-10-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 24 may 2024 on moto partial knee 02.18.Tf4.Rm tibial tray fix cemented s4 rm (k162084) lot.2003450 lot 2003450: 20 items manufactured and released on 22-july-2020.Expiration date: 2025-07-13.No anomalies found related to the problem.To date, 20 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision surgery 2 years and 1 month post primary for pain in the lateral compartment and the cause is unknown.The surgeon converted the patient from a uni to a sphere knee.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM
• Common Device Name: KBEE PARTIAL KNEE SZSTEM 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: 19565506
• Report Number: 3005180920-2024-00418
• Device Sequence Number: 6305794
• Product Code: HSX
• UDI-Device Identifier: 07630030895586
• UDI-Public: 07630030895586
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2024
• 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): 06/19/2024

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: 06/02/2025
• Device Catalogue Number: 02.18.003RM
• Device Lot Number: 2001410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2020
• 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 Sex: Unknown