MAUDE Adverse Event Report: AESCULAP AG AS ENDURO MENISCAL COMPONENT F3 12MM; KNEE ENDOPROSTHESES

Model Number	NR891Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information / investigation results will be provided in a supplemental report, if received.
Event or Problem Description
It was reported that there was an issue with as enduro meniscal component.After opening up the incision, during a hinged knee revision, it appeared that the locking ring had come off, which caused the hinge to detach.The peek bushing was loose and disintegrated; the poly was also dislodged from the tibial baseplate.Upon examining the implant, the surgeon was able to keep the implant in place and replace the poly insert, bushing and locking ring.The extensor mechanism was recreated/replaced with allograft material.The surgeon cleaned up the black tissue and closed the patient.There was a comment noted that the blackened tissue was metallosis, but a tissue sample was not taken.Additional information was not provided nor available.The adverse event is filed under xc reference (b)(4).
Event or Problem Description
No updates.
Additional Manufacturer Narrative
As of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: AS ENDURO MENISCAL COMPONENT F3 12MM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10970731
• Report Number: 2916714-2020-00704
• Device Sequence Number: 2178109
• Product Code: KRO
• UDI-Device Identifier: 04046963937782
• UDI-Public: 4046963937782
• 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): 12/14/2021
• Report Date (Section F): 12/08/2020

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 Model Number: NR891Z
• Device Catalogue Number: NR891Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2020
• 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: 12/08/2020
• Supplement Report FDA Received Date: 12/14/2021
• 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: 12/08/2020