MAUDE Adverse Event Report: AESCULAP AG COLUMBUS® REVISION F; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	NR147M
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
An outside law firm reported that a patient experienced failure of a right knee prosthesis that required revision surgery.According to the operative report dated (b)(6) 2025, the patient underwent revision arthroplasty of the right knee due to a failed right total knee replacement.The operative report indicates that the femoral and tibial components were grossly loose, with minimal cement adherence noted.The surgeon documented a suspected cement adhesion issue associated with the prior implant.The existing prosthetic components were easily removed with minimal bone loss.The femur and tibia were prepared and revision components were implanted using bone cement.Trialing reportedly demonstrated appropriate alignment and stability through range of motion.The wound was irrigated and closed in layers, and the patient was transferred to recovery in stable condition.No intraoperative complications were reported in the operative record.

• Brand Name: COLUMBUS® REVISION F
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 24639446
• Report Number: 3005673311-2026-00041
• Device Sequence Number: 15970006
• Product Code: JWH
• UDI-Device Identifier: 04046964009594
• UDI-Public: (01)04046964009594(11)220707(17)270706(10)52769440
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2026
• Report Date (Section F): 03/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NR147M
• Device Catalogue Number: NR147M
• Device Lot Number: 52769440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/03/2026
• Device Age: 35 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 03/19/2026