MAUDE Adverse Event Report: AESCULAP AG VEGA PS+ GLIDING SURFACE T2/2+ 16MM; KNEE ENDOPROSTHETICS

Model Number	NX223
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that there was an issue with a component of columbus knee implants.According to the complainant the patient required a revision procedure due to an infection.Reportedly the origin of the infection is unknown.The patient underwent a revision procedure on (b)(6) 2024.The adverse event is filed under aic reference (b)(4).
Event or Problem Description
Update: the product code was updated to nx223 - vega ps+ gliding surface t2/2+ 16mm.
Additional Manufacturer Narrative
Additional information: a section: patient data updated b5 - updated description d1-2, d4, d6: product information updated and explant date f9 approximate age of device h4: manufacture date manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: VEGA PS+ GLIDING SURFACE T2/2+ 16MM
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 21041223
• Report Number: 3005673311-2024-00002
• Device Sequence Number: 8539456
• Product Code: JWH
• UDI-Device Identifier: 04046963811211
• UDI-Public: (01)04046963811211(11)210420(17)260419(10)52681778
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025
• Report Date (Section F): 12/30/2024

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 Expiration Date: 04/16/2026
• Device Model Number: NX223
• Device Catalogue Number: NX223
• Device Lot Number: 52681778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/06/2024
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/04/2025
• 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 Age: 77 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/30/2024