MAUDE Adverse Event Report: AESCULAP AG AS ENDURO TIBIAL COMP.OFFSET CEMENTED T3; KNEE ENDOPROSTHETICS

Model Number	NB013Z
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available it will be submitted in a supplemental report.
Event or Problem Description
It was reported that there was an issue with the enduro tibial component.The type of the procedure/ indication was a knee revision surgery.The patient was noted to have had an infection unrelated to the implant.A revision surgery was necessary.Additional information has been requested but not yet received as of this report.The adverse event / malfunction is filed under (b)(4).
Event or Problem Description
No updates.
Additional Manufacturer Narrative
Investigation failure description up to now no product available.Therefore a failure description at the product is not possible.Investigation up to now, no product available.Therefore a failure description at the product is not possible.Pictorial documentation up to now, no product and no picture are available.Batch history review the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and conclusion based on the information received, it is not possible to determine the root cause for the mentioned infection.As mentioned "patient got infection unrelated to implant" we assume the failure is not product related.Corrective action a capa is not necessary.

• Brand Name: AS ENDURO TIBIAL COMP.OFFSET CEMENTED T3
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10823077
• Report Number: 2916714-2020-00615
• Device Sequence Number: 19666785
• Product Code: KRO
• UDI-Device Identifier: 04046963177478
• UDI-Public: 4046963177478
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021
• Report Date (Section F): 11/11/2020

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 Expiration Date: 08/31/2020
• Device Model Number: NB013Z
• Device Catalogue Number: NB013Z
• Device Lot Number: 52166662
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 05/07/2021
• 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
• Date Report Sent to FDA: 11/11/2020