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

Catalog Number	02.18.004LM
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary left knee surgery on (b)(6) 2020.The patient came in reporting pain due to a loose tibial component.The cause of the loose tibial component is unknown.The surgeon revised the tibial tray and insert.The surgery was completed successfully.Presently on 25 (b)(6) 2024, the patient came in reporting pain and the cause is unknown.The surgeon revised the patient from a uni to a total knee revising the femur implanted on (b)(6) 2020 during primary knee surgery too.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 30 january 2024; lot 1910813: (b)(4) items manufactured and released on 10-mar-2020.Expiration date: 2025-02-24.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 devices involved: batch reviews performed on 30 january 2024 moto partial knee 02.18.If5.09.Lm tibial insert fix s5 lm - 9mm (k162084) lot 168019: (b)(4) items manufactured and released on 24-jan-2017.Expiration date: 2021-12-20.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.Moto partial knee 02.18.Tf5.Lm tibial tray fix cemented s5 lm (k162084) lot 2003446: 25 items manufactured and released on 20-jul-2020.Expiration date: 2025-07-09.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.Same patient of mdr 3005180920-2021-00479, in this case we have also the patient age, 59 years old.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM
• Common Device Name: KNEE UNICOMPARTIMENTAL FEMUR
• 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: 18702080
• Report Number: 3005180920-2024-00054
• Device Sequence Number: 12566897
• 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: 2024
• 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): 02/14/2024

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: 02/24/2025
• Device Catalogue Number: 02.18.004LM
• Device Lot Number: 1910813
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2020
• 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: 59 YR
• Patient Sex: Male