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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE LMC TIBIAL LINER #5 H14 RIGHT
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LIMACORPORATE LMC TIBIAL LINER #5 H14 RIGHT Back to Search Results
Lot Number 2016145
Device Problems Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
By checking the manufacturing charts of the involved lot# 2016145, no pre-existing anomaly was found on a total of 7 items manufactured with the same lot#.No other complaints received on the same lot#.Components will be returned to limacorporate for further investigation.A final incident report will be sent once the investigation will be completed.
 
Event Description
Intra-operative issue experienced on (b)(6) 2022 during a knee surgery: the tibial liner (lmc tibial liner #5 h14 right - product code 6536.54.514, lot 2016145 ster 2100182) did not fit into the tibial plate.According to the info reported, the liner kept popping out after being put into place.Due to this issue, surgeon removed the implant and check for debris founding none.A new size #5 liner was then implanted successfully.A total of 25 minutes have been experienced due to this issue.Event happened in us.
 
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Brand Name
LMC TIBIAL LINER #5 H14 RIGHT
Type of Device
LMC TIBIAL LINER #5 H14 RIGHT
Manufacturer (Section D)
LIMACORPORATE
via nazionale 52
villanova di san daniele, udine
IT 
MDR Report Key15081835
MDR Text Key304717179
Report Number3008021110-2022-00059
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
PMA/PMN Number
K201084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number2016145
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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