MAUDE Adverse Event Report: AESCULAP AG COLUMBUS REV F MC GLID.SURF.T2/2+ 12MM; KNEE ENDOPROSTHETICS

Model Number	NR121M
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: 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 knee implant (part # nr121m) was implanted during a primary procedure performed in (b)(6) 2020.According to the complainant, the patient complained that her knee felt loose and unstable.The patient underwent a revision procedure on (b)(6) 2022, the surgeon opened the patient, debrined the area and implanted a thicker poly and tightened the joint space.The complaint device was not returned to the manufacturer for evaluation.A revision surgery was necessary and it was reported that the surgery on (b)(6) 2022 was a revision of a revision.The date of the previous revision is unknown at this time.Additional information was received on april 19, 2022 which revealed that the surgery was successfully completed with no intraoperative issues and no reports of any post operative complications.The malfunction is filed under aic reference (b)(4).
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.
Event or Problem Description
No updates required.

• Brand Name: COLUMBUS REV F MC GLID.SURF.T2/2+ 12MM
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 14319954
• Report Number: 2916714-2022-00048
• Device Sequence Number: 20118130
• Product Code: JWH
• UDI-Device Identifier: 04046964009433
• UDI-Public: 4046964009433
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/16/2022
• Report Date (Section F): 05/06/2022

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: 03/31/2021
• Device Model Number: NR121M
• Device Catalogue Number: NR121M
• Device Lot Number: 52231435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/19/2022
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/16/2022
• 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: Female
• Date Report Sent to FDA: 05/06/2022