MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM; KNEE CEMENTED FEMUR

Model Number 02.18.004RM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 26.Feb.2021: lot 2004506: (b)(4) items manufactured and released on 10-lug-2020.Expiration date: 2025-07-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional devices involved batch reviews performed on 26.Feb.2021: moto partial knee 02.18.If3.09.Rm tibial insert fix s3 rm - 9mm (k162084) lot 168055: (b)(4) items manufactured and released on 9-jan-2017.Expiration date: 2021-12-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Moto partial knee 02.18.Tf3.Rm tibial tray fix cemented s3 rm (k162084) lot 1910822: (b)(4) items manufactured and released on 26-mar-2020.Expiration date: 2025-03-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in 3 months after the primary surgery due to signs of infection and the pathogen is unknown.The surgeon removed all components and implanted medacta femur and insert with antibiotic cement to act as a spacer.The surgery was completed successfully.

Event Description

The patient came in 3months after the primary surgery due to signs of infection and the pathogen is unknown.The surgeon removed all components and implanted medacta femur and insert with antibiotic cement to act as a spacer.The surgery was completed successfully.This patient came in and had the spacer removed and permanent hardware implanted on (b)(6) 2021.

Manufacturer Narrative

On april 07th 2021 we have received the following information: this patient came in and had the spacer removed and permanent hardware implanted on (b)(6) 2021.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM
• Type of Device: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11493347
• MDR Text Key: 240033085
• Report Number: 3005180920-2021-00208
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895609
• UDI-Public: 07630030895609
• Combination Product (y/n): N
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

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: 02.18.004RM
• Device Catalogue Number: 02.18.004RM
• Device Lot Number: 2004506
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 90