MAUDE Adverse Event Report: AESCULAP AG PATELLA 3-PEGS P4; KNEE ENDOPROSTHETICS

Model Number	NX044
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
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a patella 3-pegs p4 (part# nx044) was implanted on (b)(6) 2019.According to the event description, a surgery to replace the polyethylene component(s) had been planned for (b)(6) 2025.The adverse event is filed under aic reference xc (b)(4).Associated medwatch reports: 3005673311-2025-00032; 3005673311-2025-00033; 3005673311-2025-00035; 3005673311-2025-00036; 3005673311-2025-00037.
Event or Problem Description
It was reported to aesculap inc.That a patella 3-pegs p4 (part# nx044) was implanted on (b)(6) 2019.According to the event description, a surgery to replace the polyethylene component(s) had been planned for (b)(6) 2025.The adverse event is filed under aic reference (b)(4).Associated medwatch reports: 3005673311-2025-00032.3005673311-2025-00034.3005673311-2025-00035.3005673311-2025-00036.3005673311-2025-00037.
Additional Manufacturer Narrative
Correction: section b5 corrected to remove 3005673311-2025-00033 as this mdr id should not be associated with this event.Section f6 corrected to (b)(6) 2025.
Additional Manufacturer Narrative
Manufacturing site evaluation: 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.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: PATELLA 3-PEGS P4
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 21778294
• Report Number: 3005673311-2025-00034
• Device Sequence Number: 15431236
• Product Code: JWH
• UDI-Device Identifier: 04046963810306
• UDI-Public: (01)04046963810306(11)141023(17)190930(10)52080780
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/11/2025
• Report Date (Section F): 04/08/2025

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: 09/30/2019
• Device Model Number: NX044
• Device Catalogue Number: NX044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/18/2025
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2025
• 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: 04/04/2025
• Supplement Report FDA Received Date: 04/08/2025; 04/11/2025
• 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 Age: 81 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/08/2025