MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS CR NARROW FEMUR CEMENT.F3N L; KNEE ENDOPROSTHESES

Model Number	NN801Z
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap ag that a columbus knee system (part # n801z) was implanted during a procedure performed on (b)(6), 2021.According to the complainant, before unpacking the columbus as implant, a coating issue was observed.Reportedly, the cement pockets appeared to be without as coating.The procedure was completed using a replacement device.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference cc (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the components were examined visually and microscopically.The surface of the implant (area to which the bone cement is applied) shows visible discoloration.The discoloration is not a deviation of the material but oxidation.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a no failure of the coating of the implant was detected.There is no indication for a material-, manufacturing- or design-related failure.The discoloration is not a deviation of the material but oxidation.Such changes in color have no effect on the function or properties of the coating.This is also mentioned in the ifu.Based upon the investigations results a capa is not necessary.

• Brand Name: AS COLUMBUS CR NARROW FEMUR CEMENT.F3N L
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11456809
• Report Number: 9610612-2021-00162
• Device Sequence Number: 14333622
• Product Code: JWH
• UDI-Device Identifier: 04046963457020
• UDI-Public: 4046963457020
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NN801Z
• Device Catalogue Number: NN801Z
• Device Lot Number: 52495359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1