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

Model Number NB013Z

Device Problem Compatibility Problem (2960)

Patient Problem Unspecified Infection (1930)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

If additional information or investigation results become available it will be submitted in a supplemental report.

Event 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 Description

No updates.

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
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10823077
• MDR Text Key: 217937059
• Report Number: 2916714-2020-00615
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04046963177478
• UDI-Public: 4046963177478
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 11/11/2020,05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 11/11/2020
• Distributor Facility Aware Date: 10/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention