MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS REV F TIB.OFFSET CEMENT.T3; KNEE ENDOPROSTHESES

Model Number NR075Z

Device Problem Product Quality Problem (1506)

Patient Problem Failure of Implant (1924)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation results: the device was not provided for investigation.Therefore a investigation of the device itself was not possible.The device quality and manufacturing history records (dhr) have been checked for the available lot number, and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number with this error pattern.Based on the provided information and without a product for investigation, a clear conclusion can not be drawn.Based on the present description, we assume that there is a problem with the cementation technique.Based on the investigations, and results of the 8d report no capa is necessary.

Event Description

It was reported that there was an issue with as columbus rev f tib.Offset cement.T3.According to the complaint description issues with the cementation occured during surgery.Upon cementing final implant in, surgeon noticed cement coming out of female screw hole in tibial baseplate that holds the screw for final polyethylene/gliding surface.Concerned that upon drying, cement particles could be caught between tibial baseplate and final polyethylene/glide surface and create backside wear; or that cement may dry in the female screw end and prevent final polyethylene/glide surface screw from properly inserting.Surgeon was careful to clean everything out and there were no issues in end.Per additional information received, there was no patient harm, and actually just a small surgery delay.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

• Brand Name: AS COLUMBUS REV F TIB.OFFSET CEMENT.T3
• Type of Device: KNEE ENDOPROSTHESES
• 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: 10756644
• MDR Text Key: 213883549
• Report Number: 9610612-2020-00739
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083772
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NR075Z
• Device Catalogue Number: NR075Z
• Device Lot Number: 52588151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1