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

Model Number AE-QAS-K521-99

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Investigation results: the affected device was not available for investigation.Therefore an investigation of the device was not possible.Due to the lack of the information an batch history review is not possible.The determination of a definite root cause is due to the non-availability of important information and the device itself not possible.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 that there was an issue with ae-qas-k521-99-collect.No.Qas knee implants vega it was reported on 18jul2018, that as a result of having the product implanted, the patient has experienced an issue which is unknown to aesculap.The primary surgery occurred on an unknown date, and the revision surgery occurred on (b)(6) 2013.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

• Brand Name: COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN
• 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: 11219276
• MDR Text Key: 230938936
• Report Number: 9610612-2020-00830
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention