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

Model Number	NX056Z
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 number: (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 no.(b)(4).Correction: a1 patient identifier.Additional information: a3a patient sex.D1, d2, d4 device information received.F9 approximate age of device.Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
The patient underwent revision total knee arthroplasty of the left knee for loosening of prior components.On (b)(6) 2024, the patient underwent revision knee surgery for a loose patellar button.The patellar button was removed easily with a rongeur and osteotome.A new patellar button was not implanted due to inadequate bone stock and risk of loosening.The femoral and tibial components were assessed and appeared stable.The joint was irrigated, vancomycin powder was placed intra-articularly, and the capsule was closed.The patient was transferred to pacu in stable condition.On (b)(6) 2024, the patient returned with evidence of femoral and tibial component loosening.A midline incision and medial parapatellar approach were used.The tibial component was removed after cement at the bone interface was disrupted and the implant was knocked free.The femoral component was then removed with use of a saw and osteotome after circumferential release.Approximately one-third of the femur was lost during removal.An antibiotic-impregnated spacer was implanted, and the joint was closed following irrigation and vancomycin powder application.The patient was transferred to pacu in stable condition.On (b)(6) 2025, the patient underwent removal of the antibiotic spacer and revision total knee arthroplasty with femoral and tibial replacement.Preoperative diagnosis was infection and inflammatory reaction to prior knee prosthesis.After removal of the spacer, the joint was prepared, and femoral and tibial components were implanted using cement fixation.An allograft was used for additional support.The procedure was completed without complication, and the patient was transferred to pacu in stable condition.
Additional Manufacturer Narrative
The adverse event is filed under ais reference no.(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 no.(b)(6) (b)(4).Additional information: b6 - relevant test results, b7 - patient medical history.

• 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: 22205722
• Report Number: 3005673311-2025-00046
• Device Sequence Number: 6887342
• Product Code: JWH
• UDI-Device Identifier: 04046963810474
• UDI-Public: (01)04046963810474(11)161013(17)260930(10)52279572
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/10/2025
• 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 Expiration Date: 09/30/2026
• Device Model Number: NX056Z
• Device Catalogue Number: NX056Z
• Device Lot Number: 52279572
• 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: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2025
• 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: 06/13/2025
• Supplement Report FDA Received Date: 06/27/2025; 09/08/2025; 10/02/2025; 12/10/2025
• 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: 64 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/13/2025