MAUDE Adverse Event Report: AESCULAP INC. AS TIBIA EXTENS.STEM 14X92MM CEMENTLESS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	NX085Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
The adverse event is filed under aescualp ag (b)(4).It was reported that there was an issue with a component of columbus knee system.According to the complaint description, there was postoperative right knee pain and the past implants had "fallen apart".
Additional Manufacturer Narrative
The adverse event is filed under aic reference: (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.Additional information: d1, d2a, d2b, d4 item information updated.D6b explant date.F9 approximate age of device.
Additional Manufacturer Narrative
The adverse event is filed under ais reference xc (b)(4).Investigation results: visual inspection: the complained devices show several traces of use.The stem is still fixed in the tibial component.The tibial component shows massive damages caused due to external forces.The femoral component with the still fixed stem shows normal signs of use without any serious damages.Some bone cement residues are still adhesive on the intended area.The gliding surface of the meniscal component shows nearly no scratches or imprints.Batch history review: the device history records have been checked for all leading device(s) lot numbers and the products found to be according to specification valid at the time of production.There are no similar complaints against the same lot number.Conclusion/preventive measures: based on the current information a clear conclusion for the revision cannot be drawn.Besides the massive damages caused due to external forces most probably during the revision procedure, the explants show no deviation or visible failures.There is no indication for a design-, manufacturing- and/or material-related failure.

• Brand Name: AS TIBIA EXTENS.STEM 14X92MM CEMENTLESS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 22152665
• Report Number: 3005673311-2025-00041
• Device Sequence Number: 13075208
• Product Code: JWH
• UDI-Device Identifier: 04046963810658
• UDI-Public: (01)04046963810658(11)110704(17)210630(10)51649247A
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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): 08/08/2025
• Report Date (Section F): 06/05/2025

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: 06/30/2021
• Device Model Number: NX085Z
• Device Catalogue Number: NX085Z
• Device Lot Number: 51649247A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/05/2025
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2025
• 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: 06/05/2025
• Supplement Report FDA Received Date: 06/20/2025; 08/08/2025
• 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: 64 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/05/2025