MAUDE Adverse Event Report: AESCULAP AG COLUMBUS CR FEMORAL COMP.CEMENTED F4R; KNEE ENDOPROSTHETICS

Model Number NN210

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

If follow-up information or manufacturing investigation is provided, a supplemental report will be submitted.

Event Description

It was reported that there was an issue with as columbus knee.Due to mal-rotation of originally implanted devices, a second surgery was required.It was noted that the implants were not defective but had been inserted incorrectly.The primary procedure occurred on an unspecified date, and the revision was performed on (b)(6) 2020.The implants were removed and revised to a columbus revision knee.The patient outcome was good.All available information has been provided at this time.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00457, 2916714-2020-00458.

Event Description

No updates.

Manufacturer Narrative

The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00457, 2916714-2020-00458, 2916714-2020-00459.Reference code nn071kdevice name.Columbus cr/ps tib.Plateau cemented t1.Serial number n/a.Batch number unknown.Udi device identifier (b)(4).Udi production identifier unknown.Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date unknown.Ref.Code device name batch nr.Nn210 columbus cr dd glid.Surface t1/1+ 10mm unknown.Nn014k columbus cr femoral comp.Cemented f4r unknown.Investigation: no product at hand.Therefore an investigation at the product is not possible.Pictorial documentation: there are no pictures available.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Explanation and rationale: the root cause for the revision is not product related see case description: "revision not due to any defects of implanted items.Revision due to mal-rotation of originally implanted items".Corrective action according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.

• Brand Name: COLUMBUS CR FEMORAL COMP.CEMENTED F4R
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10528668
• MDR Text Key: 206954558
• Report Number: 2916714-2020-00459
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NN210
• Device Catalogue Number: NN210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR