MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S1 RM

Model Number	02.18.001RM
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 years and 11 months after primary, the patient came in reporting instability and the cause is unknown.The surgeon converted the patient from a moto knee to a total knee system.The surgery was completed successfully.Patient reported that she lost 125 pounds and said the knee didn't feel the same.
Additional Manufacturer Narrative
Batch review performed on 10-feb-2025: lot 189247: (b)(4) items manufactured and released on 22-jan-2019.Expiration date: 10-jan-2024.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.Additional devices involved.Batch reviews performed on 10-feb-2025: moto partial knee 02.18.If1.08.Rm tibial insert fix s1 rm - 8mm lot.177886 (k162084) lot 177886: (b)(4) items manufactured and released on 29-mar-2018.Expiration date: 13-mar-2023.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.Tf1.Rm tibial tray fix cemented s1 rm (k162084) lot 160679: (b)(4) items manufactured and released on 11-oct-2016.Expiration date: 29-may-2021.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.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S1 RM
• 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: 21467673
• Report Number: 3005180920-2025-00130
• Device Sequence Number: 17017178
• Product Code: HSX
• UDI-Device Identifier: 07630030895548
• UDI-Public: 07630030895548
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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: 01/10/2024
• Device Model Number: 02.18.001RM
• Device Lot Number: 189247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 79 KG