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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DIA. 15 - TRIAL STEM WITH QUICK CONNECTION
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LIMACORPORATE S.P.A. DIA. 15 - TRIAL STEM WITH QUICK CONNECTION Back to Search Results
Model Number 9013.02.151
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2023
Event Type  malfunction  
Manufacturer Narrative
No pre-existing anomaly was detected by the check of the device history records of the lot numbers involved.A final report will be submitted after the investigation.
 
Event Description
Intraoperative issues occurred during shoulder surgery on (b)(6) 2023.The trial stem was released from the humeral body and remained in the bone, it was then removed with stem extractor.The surgery was extended by half an hour due to this issue.No consequences were reported for the patient.According to the information received, the same issue occurred with three trial stems during the same surgery: smr - trial stem d.15 mm 901302151 lot 16ab020.Smr - trial stem d.17 mm 901302171 lot 16ab022.Smr - trial stem d.19 mm 901302191 lot 17aq0xr.Event occurred in slovakia.
 
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Brand Name
DIA. 15 - TRIAL STEM WITH QUICK CONNECTION
Type of Device
DIA. 15 - TRIAL STEM WITH QUICK CONNECTION
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via naizonale 52
villanova di san daniele, udine 33038
IT  33038
Manufacturer Contact
via nazionale 52
villanova di san daniele, udine 33038
MDR Report Key17143255
MDR Text Key317318034
Report Number3008021110-2023-00072
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K100858
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 Received06/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number9013.02.151
Device Lot Number16AB020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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