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

Model Number	NR193Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient underwent a left total knee replacement on (b)(6) 2023.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Updated information.F9 approximate age of device.Due to the circumstance that no explant was provided, an investigation at the product is not possible.For the mentioned patient´s pain and high blood pressure an investigation at the explants is not necessarily effective.It is not possible to determine from the explant alone the root cause for the mentioned patient´s problem.2.3 risks, adverse effects and interactions: within the scope of the legal obligation to provide information, reference is made to the typical risks, interactions.And side effects listed below.Possible risks, side effects and interactions of the application currently known to the manufacturer are: - dislocation, loosening, wear, corrosion, disconnection and breakage of the implant components.- malalignment of anatomical structures, including loss of correct knee alignment, loss of varus and/or valgus correction.- decrease in bone density or loss of bone substance due to resorption or stress shielding.- skin or muscle sensitivity in patients with insufficient tissue coverage at the operation site.- joint dislocation and postoperative changes in leg length.- primary and secondary infections.- periprosthetic fractures.- thromboses, embolisms.- tissue reaction to implant materials.- injury to the surrounding tissue, including nerve and vascular damage.- haematoma and wound healing disorders.- periarticular calcification, periarticular adhesion and fibrosis.- reduced joint mobility and flexibility.- limited load-bearing ability of the joint and joint pain.On the basis of the current information, a conclusion regarding the patient's pain and high blood pressure cannot be drawn.The device history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are zero (0) similar complaints against the same lot numbers.Review of the products change history and consultation of the relevant subject matter expert (sme) did not reveal changes that may have had an influence / contribution to the reported issue.

• 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: 22913039
• Report Number: 3005673311-2025-00099
• Device Sequence Number: 9266745
• Product Code: KRO
• UDI-Device Identifier: 04046963176129
• UDI-Public: (01)04046963176129(17)290430(10)52519393
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025
• Report Date (Section F): 08/28/2025

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: NR193Z
• Device Catalogue Number: NR193Z
• Device Lot Number: 52519393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/08/2025
• Device Age: 76 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/12/2025
• 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: 68 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/28/2025