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

Model Number AE-QAS-K521-56

Device Problem Patient-Device Incompatibility (2682)

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

Event Type  Injury  

Manufacturer Narrative

Reference code (b)(4).Device name collect.No.Qas knee impl.Vega, serial number n/a, batch number unknown, udi device identifier n/a, udi production identifier unknown, basic udi-di n/a, unit of use udi-di n/a, manufacturing date unknown.Investigation: no product at hand.Therefore an investigation at the device is not possible.Pictorial documentation: there are no pictures available.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.Explanation and rationale: in the light of the little information received and due the circumstance that we did not received the complained devices it is not possible to determine an exact conclusion and root cause.Corrective action: for this topic a product safety case (psc) was initiated.

Event Description

It was reported that there was an issue with as vega knee.There was an unspecified malfunction or injury.The primary implantation was performed on (b)(6) 2013, and revision occurred on (b)(6) 2016.A revision was necessary.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 reference (b)(4).

• Brand Name: COLLECT.NO.QAS KNEE IMPL.VEGA
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11132854
• MDR Text Key: 226315098
• Report Number: 2916714-2020-00687
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2021
• Distributor Facility Aware Date: 07/18/2018
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention