MAUDE Adverse Event Report: AESCULAP AG AS VEGA SYSTEM® PS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	NX029Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adverse event is filed under aesculap reference no.(b)(4).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 system.According to the complaint description, this knee implant was "defective and failed prematurely because the ceramic coated surface fails to properly adhere to the cement".There was postoperative mechanical loosening.It was noted that the surgeon easily removed the implant by hand during the revision.Additional information was not provided.
Additional Manufacturer Narrative
The adverse event is filed under aesculap reference no.(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 aesculap reference no.(b)(4).Additional information: a section: patient data, b5: description updated, b6: test results, b7: medical history, d1&2: brand name, common device name, product code, d3: material, batch, expiration date, d6: implant and explant dates, f9: approximate age of device.
Event or Problem Description
The medical device was updated to nx029z - as vega ps femoral comp.Cemented f4n r.This was implanted in the right knee on (b)(6) 2021.
Additional Manufacturer Narrative
The adverse event is filed under aesculap reference no.(b)(4).Additional information: b5 - description updated correction f9 approximate age of device.
Event or Problem Description
An outside law firm reported that a patient experienced complications following a right knee prosthesis that required subsequent medical intervention.According to the operative report dated (b)(6) , 2021, the patient underwent a primary right total knee arthroplasty for tricompartmental degenerative joint disease (djd) with varus deformity.The procedure was performed using aesculap vega components, which were cemented in place using palacos bone cement.The operative report indicates that the components were implanted with appropriate alignment and stability, with central patellar tracking and no evidence of varus or valgus instability.The patient tolerated the procedure well and was taken to recovery in good condition.No intraoperative complications were reported.According to a subsequent operative report dated (b)(6) , 2025, the patient underwent a revision right total knee arthroplasty due to failure of the prior knee replacement with loosening of components.Intraoperatively, both the femoral and tibial components were noted to be loose with fragmentation of cement and were removed without significant difficulty.Revision was performed using another manufacturer's components with stemmed femoral and tibial implants, which were cemented in place using palacos bone cement.Trialing and final implantation demonstrated full extension and flexion with no medial or lateral instability.The operative report indicates that the patient was taken to recovery in good condition and no intraoperative complications were reported.

• Brand Name: AS VEGA SYSTEM® PS
• 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: 22205721
• Report Number: 3005673311-2025-00048
• Device Sequence Number: 17864245
• Product Code: JWH
• UDI-Device Identifier: 04046963810122
• UDI-Public: (01)04046963810122(11)191107(17)291106(10)52557102
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/20/2026
• Report Date (Section F): 06/13/2025

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: NX029Z
• Device Catalogue Number: NX029Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2025
• Device Age: 68 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/27/2025; 03/18/2026; 03/20/2026
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American
• Date Report Sent to FDA: 06/13/2025