MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS VEGA; KNEE ENDOPROSTHESES

Model Number AE-QAS-K521-56

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information, investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with an unknown vega knee implant.The article code of the device is unknown.According to the complaint description, a revision surgery was necessary.The patient underwent knee replacement surgeries (left knee (b)(6) 2017) and right knee (b)(6) 2017.Subsequent revision surgery was performed on (b)(6) 2019.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

A1: added patient identifier.Investigation results: 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 neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.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: COLLECT.NO.QAS KNEE IMPLANTS VEGA
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11628110
• MDR Text Key: 244210891
• Report Number: 9610612-2021-00277
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

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
• Device Operator: Health Professional
• Device Model Number: AE-QAS-K521-56
• Device Catalogue Number: AE-QAS-K521-56
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention