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

Model Number AE-QAS-K521-55

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

If additional information or investigation results are provided, they will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with an unknown knee implant - as enduro system.According to the complaint description, the knee was replaced due to a "defect".The patient underwent left knee replacement surgery on (b)(6) 2019.A revision surgery was performed on (b)(6) 2020.A revision surgery was necessary.Additional information was not provided.The adverse event is filed under xc reference (b)(4).

Manufacturer Narrative

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.A capa is not necessary.

Event Description

No updates.

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11814046
• MDR Text Key: 252014359
• Report Number: 2916714-2021-00071
• Device Sequence Number: 1
• Product Code: KRO
• 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: 05/12/2021,09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-QAS-K521-55
• Device Catalogue Number: AE-QAS-K521-55
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2021
• Distributor Facility Aware Date: 04/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention