MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES TRIAL - POLY; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2018

Event Type  malfunction  

Event Description

It was reported that the trial is deeply gouged, spd/surgeon concerned it poses a contamination risk and or chunks will fall in patient, they are requesting formal investigation and response for this type of damage and replacement.Our rep would like an investigation as to status of possible future gouged trials and if they would pose a risk so they can give to customer, and we would not need to necessarily replace trials if they will pose no risk.

Manufacturer Narrative

H10 h3, h6: the device, used for treatment, was not returned for evaluation.There was no part/serial/lot number provided for dhr review so it could not be concluded if the device met the manufacturing specifications.A complaint history review identified similar events.We were able to confirm there was a relationship established between the reported event and the device.Visual inspection of a photograph provided by the site revealed that the poly trial was most likely broken from wear and tear from repeated uses.The size c poly trials (this case was a size c 9mm) are the most commonly used as they fit into the size 5 and 6 tibial base plates.The malfunction is likely due to wear and tear from repeated uses.

• Brand Name: TRIAL - POLY
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9998988
• MDR Text Key: 189320197
• Report Number: 3010266064-2020-00931
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K123380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1