MAUDE Adverse Event Report: AESCULAP AG COLUMBUS CR DD GLID.SURFACE T1/1+ 14MM; KNEE ENDOPROSTHETICS

Model Number	NN212
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was patient implanted with a columbus cr dd glid.Surface t1/1+ 14mm (part # nn212) on an unspecified date.Reportedly the patient had significant stiffness and has a revision surgery scheduled for (b)(6) 2024.The revision will be for a right total knee arthroplasty of polyethylene exchange.An implant kit was confirmed to be available for shipment to the customer facility.
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected information: d4 primary unique udi number.Additional information: f9 approximate age of device.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 CR DD GLID.SURFACE T1/1+ 14MM
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 20416157
• Report Number: 2916714-2024-00159
• Device Sequence Number: 8209605
• Product Code: JWH
• UDI-Device Identifier: 04038653358878
• UDI-Public: (01)04038653358878(17)230430(10)52431595
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024
• Report Date (Section F): 10/10/2024

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 Expiration Date: 04/30/2023
• Device Model Number: NN212
• Device Catalogue Number: NN212
• Device Lot Number: 52431595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/13/2024
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/01/2024
• 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 Age: 50 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/10/2024