MAUDE Adverse Event Report: AESCULAP AG COLUMBUS REV F MC GLID.SURF.T3/3+ 16MM; KNEE ENDOPROSTHETICS

Model Number NR133M

Device Problems Fitting Problem (2183); Compatibility Problem (2960); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 07/21/2020

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 columbus knee component.There was a revision of a columbus revision implant.Postoperatively at some time, surgeon suspected that the femoral component may be loose.It was, however, very well fixated.The patient had been experiencing pain and tightness in knee, especially during flexion.Surgeon exchanged polyethylene insert from 16mm mc to 12mm hc revision insert and repaired tight patella/femoral compartment.It was noted that during the original procedure, the implant had been put in a bit too tight and the knee was not flexing well.A revision surgery was necessary.The procedure was a success and patient outcome was good.Additional patient information is not available.The removed implant was discarded.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Reference code nr133m, device name columbus rev f mc glid.Surf.T3/3+ 16mm, 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.Investigation: no product at hand, therefore an investigation 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: on the basis of the current information and without a product for investigation, a clear conclusion cannot be drawn.According to the provided information a product related error is unlikely: "the original implant that was put in was a bit too tight and the knee was not flexing well.The surgeon took the old 16mm insert out and replaced it with a 12mm." corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.

Event Description

No updates.

• Brand Name: COLUMBUS REV F MC GLID.SURF.T3/3+ 16MM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10402291
• MDR Text Key: 203514025
• Report Number: 2916714-2020-00317
• Device Sequence Number: 1
• Product Code: JWH
• 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: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NR133M
• Device Catalogue Number: NR133M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/07/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention