MAUDE Adverse Event Report: AESCULAP AG AS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	NR404Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
An outside law firm reported that a patient experienced issues following a left knee prosthesis that required subsequent medical intervention.According to the operative report dated (b)(6) 2022, a patient underwent a left total knee arthroplasty 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.According to a subsequent operative report dated (b)(6) 2023, 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, bone cement, and adjunctive materials including antibiotic beads.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.A follow-up clinic note dated (b)(6) 2025, documents ongoing left knee pain and effusion.Range of motion was reported as normal with maintained alignment.No infection was documented.
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.

• Brand Name: AS
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 24661553
• Report Number: 3005673311-2026-00050
• Device Sequence Number: 14731799
• Product Code: KRO
• UDI-Device Identifier: 04046963176549
• UDI-Public: (01)04046963176549(11)210301(17)310228(10)52668112
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2026
• Report Date (Section F): 03/23/2026

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: NR404Z
• Device Catalogue Number: NR404Z
• Device Lot Number: 52668112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/03/2026
• Device Age: 60 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2026
• 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 Sex: Female
• Patient Weight: 104 KG
• Date Report Sent to FDA: 03/23/2026