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

Model Number 02.18.003RM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 04/12/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 19 april 2023: lot 2105455: (b)(6) items manufactured and released on 18-may-2021.Expiration date: 2026-05-04.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Additional devices involved: batch reviews performed on 19 april 2023 moto partial knee 02.18.If4.08.Rm tibial insert fix s4 rm - 8mm (k162084) lot 2103536: (b)(6) items manufactured and released on 05-may-2021.Expiration date: 2026-04-22.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold without any similar reported event during the period of review.Moto partial knee 02.18.Tf4.Rm tibial tray fix cemented s4 rm (k162084) lot 2103556: (b)(6) items manufactured and released on 27-may-2021.Expiration date: 2026-05-11.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold without any similar reported event during the period of review.

Event Description

At about 1 year 6 months after the primary, the patient came in reporting pain and the cause is unknown.The surgeon revised the patient from moto to sphere and the surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM
• Type of Device: KNEE CEMENTED 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: 16885914
• MDR Text Key: 314733846
• Report Number: 3005180920-2023-00334
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895586
• UDI-Public: 07630030895586
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.18.003RM
• Device Catalogue Number: 02.18.003RM
• Device Lot Number: 2105455
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2021
• 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 Sex: Male