MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS VEGA; KNEE ENDOPROSTHETICS

Model Number AE-QAS-K521-56

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Ambulation Difficulties (2544); Implant Pain (4561)

Event Type  Injury  

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.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.A clear root cause conclusion cannot be drawn due to the non-availability of important information and the device itself.The conclusion from the root cause analysis is that a systematic device deviation is unlikely, since the received complaints are limited to certain health care institutions and their applicants.The participation of the applicants in this deviation scenario cannot be excluded by today.Based on the root cause analysis result no corrective actions have been carried out.As a preventive action we were in contact with the affected health care institutions and applicants in order to reduce the probability of recurrence.The complaints were submitted to aesculap ag as a summary report.In order to examine further actions, all cases from the summary report are processed as vigilance suspicion cases and are continuously monitored.

Event Description

It was reported to aesculap inc.That a vega knee implant system was implanted during a primary surgery of the right and left knees performed on (b)(6) 2013.According to the complainant, following the primary surgery, the patient experienced pain and difficulty walking.There was no reported revision surgery.The complaint device was not available to be returned to the manufacturer for evaluation.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch reports: 9610612-2020-00397 (400480657 - ae-qas-k521-56).

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS VEGA
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11349139
• MDR Text Key: 241862666
• Report Number: 9610612-2020-00398
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2021

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-K521-56
• Device Catalogue Number: AE-QAS-K521-56
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other