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

Model Number NR133M

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688); Implant Pain (4561)

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.According to the customer description, it was reported that was a revision of a columbus revision implant.Initially, surgeon thought femoral component may be loose.Turns out it was very well fixated.However, patient was 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

Correction: updated h6 codes investigation results: the device was not provided for investigation.Therefore a investigation of the device itself was not possible.Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Based on the provided information and without a product for investigation, a clear conclusion can not be drawn.Due to the provided information: " 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 a12mm." a product related error is unlikely.Based on the investigations and results of the 8d report no capa is necessary.

• 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: 10402296
• MDR Text Key: 202885350
• Report Number: 9610612-2020-00380
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K122985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

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: NR133M
• Device Catalogue Number: NR133M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention