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

Model Number AE-QAS-K521-53

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with knee implant(s), (b)(6).The initial procedure was performed on (b)(6) 2020.According to the complaint description, the a revision of the implant was necessary due to an infection.The device code is unknown.A revision surgery was necessary.The implant was removed and there was a conversion to antibiotic spacer.Additional information was not provided.Results of x-rays were not available.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.Based upon the investigations results a capa is not necessary.

Event Description

No updates.

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11030815
• MDR Text Key: 222277479
• Report Number: 2916714-2020-00705
• Device Sequence Number: 1
• Product Code: JWH
• 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: 12/17/2020,09/28/2021

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-K521-53
• Device Catalogue Number: AE-QAS-K521-53
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2020
• Distributor Facility Aware Date: 11/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR