MAUDE Adverse Event Report: AESCULAP AG COLUMBUS REV F HC GLID.SURF.T1/1+ 20MM; KNEE ENDOPROSTHESES

Model Number	NR194Z
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 as tibia offset stem d12x92mm cemented (part# nr194z) was implanted on (b)(6) 2023.According to the complainant a surgery to replace the polyethylene components had been planned for (b)(6) 2025; sizes larger than 20 millimeters (mm) needed.The procedure would be revision right knee total arthroplasty (tka).Additional information was not provided but has been requested.The adverse event is filed under aic reference (b)(4).Associated medwatch reports: 3005673311-2025-00020, 3005673311-2025-00021, 3005673311-2025-00022, 3005673311-2025-00023, 3005673311-2025-00024, 3005673311-2025-00025, 3005673311-2025-00026, 3005673311-2025-00027, 3005673311-2025-00028, 3005673311-2025-00029, and 3005673311-2025-00030.
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: COLUMBUS REV F HC GLID.SURF.T1/1+ 20MM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 21755121
• Report Number: 3005673311-2025-00019
• Device Sequence Number: 13302530
• Product Code: JWH
• UDI-Device Identifier: 04046963176136
• UDI-Public: (01)04046963176136(11)220208(17)320207(10)52736524
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025
• Report Date (Section F): 04/02/2025

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: NR194Z
• Device Catalogue Number: NR194Z
• Device Lot Number: 52736524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/13/2025
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/30/2025
• 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: 60 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/02/2025