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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/13/2024

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 337619282
• Report Number: 3005180920-2024-00116
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895555
• UDI-Public: 07630030895555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.18.002LM
• Device Lot Number: 2012091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Race: White