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

Model Number	NX054Z
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 ceramic coated surface failed to properly adhere to the cement which caused the implant to fail prematurely.The patient underwent a revision surgery on (b)(6) 2025.Although requested, additional information has not yet been provided.
Additional Manufacturer Narrative
The adverse event is filed under ais reference: (b)(4).Additional information: a - patient gender.B5 - description updated.B6 - relevant test results.B7 - medical history.
Event or Problem Description
Update: additional information was received.The patient had complained of pain and stiffness of the right knee postoperatively.A revision was performed.It was reported that the patient was still out of work and attending physical therapy.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(6) (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: d1 brand name.D4 item information received.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Investigation results: the complained medical device was not available for investigation.The investigation was based upon event description, batch history review, historical data analysis, and review of pictures.The provided pictures did not provide further information.The device history records have been checked for all leading device(s) lot numbers and the products found to be according to specification valid at the time of production.Conclusion/preventive measures: based upon the investigation results, a definitive root cause for the implant loosening could not be determined.In the event that the complained device will be provided for investigation in the future, an update of this report will be provided unsolicited.

• 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: 23211173
• Report Number: 3005673311-2025-00131
• Device Sequence Number: 8919338
• Product Code: JWH
• UDI-Device Identifier: 04046963810436
• UDI-Public: (01)04046963810436(17)311130(10)52731601
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/07/2026
• Report Date (Section F): 10/03/2025

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: NX054Z
• Device Catalogue Number: NX054Z
• Device Lot Number: 52731601
• 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: 09/26/2025
• 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: 10/03/2025
• Supplement Report FDA Received Date: 10/28/2025; 12/18/2025; 03/02/2026; 04/07/2026
• 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: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/03/2025