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

Model Number AE-QAS-K521-53

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Date 12/16/2019

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 knee implants, columbus system.The following information was reported: the incident occurred on (b)(6) 2019.There was a revision of columbus as primary knee.The reason for the revision surgery was because the patient was experiencing pain, and there was no clear reason as to the reason for the pain.The x-ray results showed alignment and the implant was not loose.The patient condition after surgery was noted to be excellent.The operative report and additional patient information is not available.The adverse event is filed under (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: failure description - no product at hand, therefore a failure description is not possible.Investigation - no product at hand, therefore an investigation is not possible.Pictorial documentation - there are no pictures available.Batch history review - a review of the device quality and manufacturing history records is not possible because the material number as well as the batch number is unknown.Conclusion and root cause - based on the information available it is not possible to determine a possible root cause for the failure.Rationale - in the light of the information received and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a root cause for the mentioned failure.The information received are not usable regarding the mentioned failure.The origin of patient experiencing pain is unknown.If new information and/or the prosthesis are going to provided, a further investigation will be executed.Corrective action - according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

Event Description

No update provided.

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS
• Type of Device: PREVIOUSLY REPORTED
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9594198
• MDR Text Key: 175678082
• Report Number: 2916714-2020-00004
• Device Sequence Number: 1
• Product Code: OOG
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• 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?: No
• Distributor Facility Aware Date: 01/24/2020
• Event Location: Hospital
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention