MAUDE Adverse Event Report: AESCULAP AG AS VEGA SYSTEM® PS; KNEE ENDOPROSTHETICS

Model Number	NX033Z
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
According to the complainant there was an issue with the aesculap ceramic-coated knee implant.Reportedly the knee implant was defective and failed prematurely because the ceramic coated surface fails to properly adhere to the cement.The index surgery was performed sometime in (b)(6) 2018 revision surgery was performed on (b)(6) 2025.Additional information has been requested but not yet provided.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Investigation results: 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.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, 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.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Additional information: a - patient sex d1 brand name, d4 device information.Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).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.
Additional Manufacturer Narrative
The adverse event is filed under ais reference xc (b)(4).Additional information: b6 - test result.B7 - medical history.

• Brand Name: AS VEGA SYSTEM® PS
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 23193461
• Report Number: 3005673311-2025-00130
• Device Sequence Number: 18398552
• Product Code: JWH
• UDI-Device Identifier: 04046963810207
• UDI-Public: (01)04046963810207(17)280430(10)52424040
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/18/2026
• Report Date (Section F): 10/01/2025

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: NX033Z
• Device Catalogue Number: NX033Z
• Device Lot Number: 52424040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/26/2025
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 10/28/2025; 12/04/2025; 12/18/2025; 03/18/2026
• 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 Age: 56 YR
• Patient Sex: Male
• Date Report Sent to FDA: 10/01/2025