MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN; KNEE ENDOPROSTHETIC

Model Number AE-QAS-K521-99

Device Problems Mechanical Problem (1384); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Implant Pain (4561)

Event Date 06/12/2020

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 collect.No.Qas knee implants.The patient had an unspecified aesculap knee replacement surgery on (b)(6) 2019.It was noted that the patient began experiencing pain 6 months ago.The procedure to have the knee revised was scheduled for (b)(6) 2020.Additional information has been requested but was not yet available.The adverse event / malfunction is filed under 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 IMPL.MISC./UNKNOWN
• Type of Device: KNEE ENDOPROSTHETIC
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10258469
• MDR Text Key: 203471903
• Report Number: 2916714-2020-00223
• Device Sequence Number: 1
• Product Code: HRY
• 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: 07/10/2020,05/12/2021

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-K521-99
• Device Catalogue Number: AE-QAS-K521-99
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2020
• Distributor Facility Aware Date: 06/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention