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

Model Number AE-QAS-K521-99

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 02/12/2021

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 ae-qas-k521-99 -collect.No.Qas knee impl.Misc.Unknown.According to the complaint description, the patient underwent revision surgery.Additional information was not provided nor available was not available.The adverse event is filed under aag 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.

• Brand Name: COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11463163
• MDR Text Key: 248047122
• Report Number: 9610612-2021-00165
• 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
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

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
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention