MAUDE Adverse Event Report: BRAUN AESCULAP AS. COLUMBUS REVISION FEMORAL COMPONENT WITH POSTERIOR AUGMENTS 5MM MEDIAL, LATERAL,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 03/25/2020

Event Type  Injury  

Event Description

This letter is to inform you of this adverse event as the suspect device braun aesculap as columbus revision femoral component with posterior augments 5mm medial, lateral, distal augments; 19mmx177mmm 5 degree stem; revision tibial component; and revision gliding surface is not manufactured or imported by depuy synthes joint reconstruction.Event description: office note on (b)(6) 2020 indicates the patient is still experiencing pain and instability, feels as though his knee could "give way at any time".Original implant date on (b)(6) 2016.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: COLUMBUS REVISION FEMORAL COMPONENT WITH POSTERIOR AUGMENTS 5MM MEDIAL, LATERAL,
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): BRAUN AESCULAP AS.
• MDR Report Key: 17533663
• MDR Text Key: 321151675
• Report Number: MW5140567
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: 19MMX177MMM 5 DEGREE STEM., REVISION TIBIAL COMPON.