MAUDE Adverse Event Report: AESCULAP AG AS; PROSTHESIS, 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
Additional Manufacturer Narrative
The adverse event is filed under ais reference (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.
Event or Problem Description
According to the complainant the knee implant was defective and failed prematurely because the ceramic coated surface fails to properly adhere to the cement.Additional information has been requested but not yet provided.
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
An outside law firm reported that a patient experienced post-operative loosening following a left knee arthroplasty procedure that required subsequent medical intervention.According to the operative report dated on (b)(6) 2018, the patient underwent a primary left total knee arthroplasty for degenerative joint disease (djd).The procedure was performed using cemented components, and the operative report indicates that the implants were placed with appropriate alignment and stability.The patient tolerated the procedure well and was transferred to recovery in stable condition.No intraoperative complications were reported.According to a subsequent operative report dated on (b)(6) 2025, the patient underwent a revision left total knee arthroplasty due to failed prior knee prosthesis with loosening of components.Intraoperatively, the tibial and femoral components were noted to be loose and were removed without difficulty.Revision components were implanted using bone cement, and trialing demonstrated stability through range of motion without varus or valgus laxity.The operative report indicates that the patient was taken to recovery in stable condition and no intraoperative complications were reported.However, a small medial tibial crack was identified after cement curing, which was noted to be stable without apparent movement and managed with postoperative immobilization and restricted weight-bearing.
Additional Manufacturer Narrative
The adverse event is filed under ais reference: (b)(4).Additional information: event description updated: b5.B6: relevant tests.B7: relevant history.D1: brand name, d2a common device name, d2b product code.D4: item information updated.D6a, d6b: implant and explant dates.F9: approximate age of device.

• Brand Name: AS
• 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: 23544715
• Report Number: 3005673311-2025-00133
• Device Sequence Number: 9449004
• Product Code: JWH
• UDI-Device Identifier: 04046963655808
• UDI-Public: (01)04046963655808(11)180201(17)280131(10)52396085
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2026
• Report Date (Section F): 11/13/2025

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: NX060Z
• Device Catalogue Number: NX060Z
• Device Lot Number: 52396085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/29/2025
• Device Age: 89 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 11/25/2025; 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: Unknown
• Date Report Sent to FDA: 11/13/2025