MAUDE Adverse Event Report: AESCULAP AG AESCULAP; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	NX044
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 an as vega 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 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 aesculap reference no.(b)(4).Additional information: d4 device information updated.F9 approximate age of device.H11 investigation updated.Investigation results: the complained product was not available for investigation.Therefore, the investigation was based upon batch history review, event description, and review of pictures.The provided pictures show that there are bone cement residues on to intended area/surface of the femoral component.The tibial component shows no bone cement residues.Batch history review: the device history records have been checked for all available lot numbers and the products found to be according to specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion/ preventive measures: based on the current information and without the product being available for investigation, a clear conclusion cannot be drawn.There is no indication for a design, manufacturing and/or material related failure.In the event that the complaint sample will be provided for investigation in the future, an update of this report will be provided unsolicited.
Additional Manufacturer Narrative
The adverse event is filed under aesculap reference no.(b)(4).Additional information: b5 - description update.B6 - relevant tests.B7 - patient medical history.
Event or Problem Description
Update: a right knee joint replacement occurred on (b)(6) 2019 for pain and decreased motion after multiple surgeries on the knee.Multiple arthroscopic procedures in 2021 were noted, with no period of improvement after tka.A revision of the tka right knee was performed on (b)(6) 2025 due to pain, instability, and aseptic loosening of the right femoral component.There was no gross evidence of infection.

• Brand Name: AESCULAP
• 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: 22210709
• Report Number: 3005673311-2025-00053
• Device Sequence Number: 8132089
• Product Code: JWH
• UDI-Device Identifier: 04038653473731
• UDI-Public: (01)04038653473731(11)190408(17)240310(10)52508155
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 12/11/2025
• 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 Expiration Date: 03/10/2024
• Device Model Number: NX044
• Device Catalogue Number: NX044
• Device Lot Number: 52508155
• 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: 6 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
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 06/27/2025; 07/31/2025; 12/11/2025
• 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 Sex: Female
• Date Report Sent to FDA: 06/16/2025