MAUDE Adverse Event Report: AESCULAP AG COLUMBUS UC GLIDING SURFACE T2/2+ 10MM; KNEE ENDOPROSTHETICS

Catalog Number	NN420
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Liver Damage/Dysfunction (1954); Implant Pain (4561)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an issue with nn420 - columbus uc gliding surface t2/2+ 10mm.According to the complaint description, the revision surgery was performed due to postoperative pain.The polyethylene component was removed and replaced with one of the same size.The adverse event is filed under aesculap ag reference (b)(4).
Additional Manufacturer Narrative
Investigation ongoing.Additional information / investigation results will be provided in a supplemental report.
Additional Manufacturer Narrative
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.

• Brand Name: COLUMBUS UC GLIDING SURFACE T2/2+ 10MM
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 20074506
• Report Number: 2916714-2024-00122
• Device Sequence Number: 19591872
• Product Code: JWH
• UDI-Device Identifier: 04038653445349
• UDI-Public: (01)04038653445349
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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 Catalogue Number: NN420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/07/2024
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 12/05/2024
• 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