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

Model Number	NR409Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adverse event is filed under aesculap reference number: (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
It was reported that there was an issue with a component of columbus knee system.According to the complaint description, this knee implant was "defective and failed prematurely because the ceramic coated surface fails to properly adhere to the cement".There was postoperative mechanical loosening.It was noted that the surgeon easily removed the implant by hand during the revision.Additional information was not provided.
Additional Manufacturer Narrative
The adverse event is filed under aesculap reference no.(b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
Update: the medical device was updated to nr409z - as femur extens.Stem 5° d19x117 cem.Less.It is now considered to be an involved component.This refers to the right knee.
Additional Manufacturer Narrative
The adverse event is filed under aesculap reference no.(b)(4).A.Section - patient data, b5.Description updated, b6.Test results, b7.Medical history, d1&2.Brand name, common device name, product code, d4.Material, batch, expiration date, d6.Explant date, f9.Approximate age of device.

• 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: 22205339
• Report Number: 3005673311-2025-00050
• Device Sequence Number: 7667974
• Product Code: KRO
• UDI-Device Identifier: 04046963176594
• UDI-Public: (01)04046963176594(11)200427(17)300426(10)52603484
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2026
• Report Date (Section F): 06/09/2025

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: NR409Z
• Device Catalogue Number: NR409Z
• Device Lot Number: 52603484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2025
• Device Age: 70 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/27/2025; 03/18/2026
• 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 Age: 58 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/09/2025