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U.S. Department of Health and Human Services

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

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BLUE BELT TECHNOLOGIES TRIAL - POLY PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
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.

 
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Brand NameTRIAL - POLY
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2828 liberty ave
suite 100
pittsburgh, pa
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
6833844
MDR Report Key9998988
MDR Text Key189320197
Report Number3010266064-2020-00931
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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