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

Model Number	NX060Z
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 ongoing issues involving the right knee following degenerative joint disease and subsequent surgical intervention.According to clinical documentation, the patient presented on (b)(6) 2021 with chronic right knee pain due to end-stage osteoarthritis, having failed conservative management including multiple injections.A right total knee arthroplasty was recommended.The patient subsequently underwent a right total knee arthroplasty on (b)(6) 2021.Operative records indicate the procedure was completed without intraoperative complications, with proper placement of prosthetic components and stable range of motion achieved intraoperatively.Following surgery, the patient was seen on (b)(6) 2021 after a reported fall, with continued pain but no immediate evidence of surgical failure.At follow-up on (b)(6) 2022, the patient was noted to be recovering fairly well, though she had difficulty attending physical therapy and continued to have weakness.On (b)(6) 2022, the patient reported ongoing knee pain with episodes of instability and falls, with examination noting ligamentous laxity.Additional treatment included a corticosteroid injection to the contralateral (left) knee.At a later follow-up on (b)(6) 2025, the patient presented with worsening right knee symptoms, including medial and lateral laxity.Imaging suggested possible changes at the femoral component, and further evaluation with ct scan was recommended.Clinical findings were consistent with possible loosening of the right knee prosthesis.The event is filed under ais reference (b)(4).

• Brand Name: AS
• Common Device Name: ROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 24998746
• Report Number: 3005673311-2026-00069
• Device Sequence Number: 18581100
• Product Code: JWH
• UDI-Device Identifier: 04046963655808
• UDI-Public: (01)04046963655808(11)210325(17)310324(10)52679492
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026
• Report Date (Section F): 04/27/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: NX060Z
• Device Catalogue Number: NX060Z
• Device Lot Number: 52679492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2026
• Device Age: 61 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2026
• 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: 04/27/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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
• Date Report Sent to FDA: 04/27/2026