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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 Break (1069)
Patient Problem Injury (2348)
Event Date 04/27/2018
Event Type  malfunction  
Event Description
It was reported that the trial poly from the stride set broke.Was found after cleaning and sterilization.
 
Manufacturer Narrative
H3, h6: the reported device, used for treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.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.The root cause could not be determined for this issue.Factors that could have contributed to the reported event may most likely be related to wear and tear from repeated uses.The size c poly trials are the most commonly used as they fit into the size 5 and 6 tibial base plates.The 8mm thickness is the most common thickness as it leaves the most room for the surgeon to size up.Therefore, they are more likely to wear than any other types poly trials.
 
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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 Key9998972
MDR Text Key189311711
Report Number3010266064-2020-00928
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
PMA/PMN Number
K123380
Number of Events Reported1
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 Received04/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received07/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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