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

Model Number 02.18.003LM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Loss of Range of Motion (2032)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 29 march 2022.Lot 1910068: (b)(4) items manufactured and released on 26-feb-2020.Expiration date: 2025-02-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional components involved: moto partial knee 02.18.Tf4.Lm tibial tray fix cemented s4 lm ((b)(4)) lot: 1910075: (b)(4) items manufactured and released on 10-feb-2020.Expiration date: 2025-01-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Moto partial knee 02.18.If4.08.Lm tibial insert fix s4 lm - 8mm ((b)(4)) lot: 2001397: (b)(4) items manufactured and released on 26-feb-2020.Expiration date: 2025-02-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

Event Description

At 1 year and 5 months after the primary, the patient came in reporting pain and tightness in the knee and the cause is unknown.The surgeon revised all components to competitor components and the surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM
• Type of Device: KNEE UNICOMPARTIMENTAL FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13950874
• MDR Text Key: 288204947
• Report Number: 3005180920-2022-00206
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895579
• UDI-Public: 07630030895579
• 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: 03/30/2022

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
• Device Operator: Health Professional
• Device Model Number: 02.18.003LM
• Device Catalogue Number: 02.18.003LM
• Device Lot Number: 1910068
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2020
• 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