MAUDE Adverse Event Report: AESCULAP AG AS; KNEE ENDOPROSTHETICS

Model Number	NX060Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
An outside law firm reported that a patient experienced ongoing complications associated with a vega knee implant.A revision surgery has not yet been scheduled.Additional information has been requested but not yet provided.This report is filed under ais reference xc (b)(4).

• Brand Name: AS
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 25484822
• Report Number: 3005673311-2026-00119
• Device Sequence Number: 9734969
• Product Code: JWH
• UDI-Device Identifier: 04046963655808
• UDI-Public: (01)04046963655808(11)210325(17)310324(10)52679492
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026
• Report Date (Section F): 06/12/2026

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: NX060Z
• Device Catalogue Number: NX060Z
• Device Lot Number: 52679492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/14/2026
• Device Age: 63 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 06/26/2026
• 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: Female
• Date Report Sent to FDA: 06/12/2026