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

Model Number	NX053Z
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
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.Xc (b)(4).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 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 ais reference no.(b)(4).Correction: a1 patient identifier.Additional information.A3a patient sex: b5 event description, d1, d2, d4 suspected medical device information, d6a, d6b implant and explant date, f9 approximate age of device.Nvestigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
The patient presented with arthrofibrosis and loosening of a prior left total knee arthroplasty.On (b)(6) 2024, the patient underwent revision total knee arthroplasty of the femur and tibia for instability and failed fixation.Intraoperatively, both the femoral and tibial components were found to be loose with minimal cement adhesion.A large lateral condyle bone cyst and osteoporotic bone were also noted.The femoral component was removed with microchoice instruments and minimal bone loss; the tibial component was similarly loose and easily removed.Excess synovium was excised.The femur and tibia were re-prepared.An intramedullary guide was placed, and trialing confirmed alignment, range of motion, and stability.Final components were implanted using third-generation cement technique.A polyethylene insert was placed, and stability was confirmed with varus/valgus stress and full range of motion testing.Vancomycin powder was applied, the wound was copiously irrigated, and the capsule and skin were closed in layers.A sterile dressing and ace wrap were applied.The patient tolerated the procedure well and 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)(4).Additional information: b5 - description updated, b7 - patient medical history.
Event or Problem Description
Update: there had been postoperative stiffness in 2022.On (b)(6) 2023, replacement of the gliding surface in the left knee was performed.
Additional Manufacturer Narrative
The adverse event is filed under ais reference no.(b)(4).Additional information: b5 - description updated, b7 - relevant history.
Event or Problem Description
An outside law firm reported that a patient experienced complications following a left knee prosthesis that required subsequent medical intervention.According to the operative report dated july 21, 2022, the patient underwent a left total knee arthroplasty (tka) for osteoarthritis.The procedure was performed using cemented knee components (aesculap system) with palacos bone cement.The operative report indicates the patient tolerated the procedure well with no intraoperative complications, and the implants were placed with appropriate alignment and stability.Following the procedure, the patient developed persistent stiffness, pain, and reduced range of motion.On (b)(6), 2022, the patient underwent manipulation under anesthesia, joint aspiration, and femoral nerve injection due to continued stiffness.Symptoms persisted despite intervention.According to a subsequent operative report dated march 27, 2023, the patient underwent a revision procedure with tibial component revision and posterior capsular release due to arthrofibrosis and stiffness.According to a later operative report dated december 23, 2024, the patient underwent a revision left total knee arthroplasty due to aseptic loosening of the femoral and tibial components.Intraoperatively, both components were noted to be grossly loose, with no cement adherent to the implants.The components were removed without significant bone loss.Revision was performed using stemmed femoral and tibial components and bone cement.Final implantation demonstrated stable fixation with appropriate alignment and full range of motion without instability.The patient tolerated the procedure and was transferred to recovery in stable condition with no intraoperative complications reported.
Event or Problem Description
Associated medwatch reports: nx011z (ais reference no.400724766; 3005673311-2025-00127).Involved components: nx062z/ as tibia extension stem 12x52mm cemented (ais reference no.(b)(4)), nx220/ vega ps+ gliding surface t2/2+ 10mm (ais reference no.(b)(4)), nx053z/ vega ps+ gliding surface t2/2+ 10mm (ais reference no.(b)(4); 9610612-2025-00097), nx220/ vega ps+ gliding surface t2/2+ 10mm (ais reference no.(b)(4)).
Additional Manufacturer Narrative
The adverse event is filed under ais reference no.Xc (b)(4).Additional information: b5: description updated, d10: involved components.

• 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: 22210710
• Report Number: 3005673311-2025-00051
• Device Sequence Number: 18175751
• Product Code: JWH
• UDI-Device Identifier: 04046963810412
• UDI-Public: (01)04046963810412(11)211103(17)311102(10)52724571
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 03/25/2026
• Report Date (Section F): 06/16/2025

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: NX053Z
• Device Catalogue Number: NX053Z
• Device Lot Number: 52724571
• 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: 52 MO
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 06/27/2025; 09/09/2025; 10/02/2025; 12/11/2025; 03/18/2026; 03/25/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NX062Z - LOT 52726062.; NX220 - LOT 52740755.; NX220 - LOT 52770790.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/16/2025