MAUDE Adverse Event Report: AESCULAP AG COLUMBUS REV F MC GLID.SURF.T2/2+ 18MM; KNEE ENDOPROSTHETICS

Model Number	NR124M
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/19/2022
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 columbus rev f mc glid.Surf.T2/2+ 18mm (part # nr124m) was implanted during a total knee arthroplasty (tka) procedure performed on an unspecified date.According to the complainant, the knee implant dislocated postoperatively on (b)(6) 2022.The patient underwent a revision surgery on (b)(6) 2022.Reportedly, the device was replaced with a similar implant.The complaint device was not available to be returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.The adverse event/malfunction is filed under aic reference (b)(4).
Event or Problem Description
Investigation complete.
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 all available lot numbers; the devices were 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 MC GLID.SURF.T2/2+ 18MM
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16183483
• Report Number: 2916714-2023-00016
• Device Sequence Number: 19405374
• Product Code: JWH
• UDI-Device Identifier: 04046964009464
• UDI-Public: 4046964009464
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023
• Report Date (Section F): 01/17/2023

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: 05/31/2024
• Device Model Number: NR124M
• Device Catalogue Number: NR124M
• Device Lot Number: 52520879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/19/2022
• Device Age: 43 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2022
• 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: 01/17/2023
• Supplement Report FDA Received Date: 02/16/2023
• 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
• Date Report Sent to FDA: 01/17/2023