MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.002LM ANATOMICAL FEMORAL COMPONENT CEMENTED S2 LM; KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED

Catalog Number	02.18.002LM
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2024.Lot 2012091: 11 items manufactured and released on 28-jan-2021.Expiration date: 2026-01-18.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported case during the period of review.Additional component involved in the event: moto partial knee 02.18.If3.08.Lm tibial insert fix s3 lm - 8mm lot.2011114 (b)(6): 28 items manufactured and released on 04-jan-2021.Expiration date: 2025-12-13.No anomalies found related to the problem.To date, 27 items of the same lot have been sold with no similar reported case during the period of review.Moto partial knee 02.18.Tf3.Lm tibial tray fix cemented s3 lm lot.2012117 (b)(6): 50 items manufactured and released on 04-mar-2021.Expiration date: 2026-02-23.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 2 years and 2 months after primary, the patient came reporting dissatisfaction with the moto implants.The surgeon revised successfully the components to a total knee system.

• Brand Name: MOTO PARTIAL KNEE 02.18.002LM ANATOMICAL FEMORAL COMPONENT CEMENTED S2 LM
• Common Device Name: KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED
• 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: 18901090
• Report Number: 3005180920-2024-00116
• Device Sequence Number: 7839402
• Product Code: HSX
• UDI-Device Identifier: 07630030895555
• UDI-Public: 07630030895555
• 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): 03/14/2024

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: 01/18/2026
• Device Catalogue Number: 02.18.002LM
• Device Lot Number: 2012091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2021
• 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: 47 YR
• Patient Sex: Female
• Patient Race: White