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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER SHORT; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER SHORT; HIP COMPONENT Back to Search Results
Model Number 26000025
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Date 05/08/2019
Event Type  Injury  
Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event Description
Allegedly, primary surgery was preformed on (b)(6) 2016.The surgeon found a dissociation after surgery and mentioned excessive stress, may have occurred during agricultural work.The surgeon performed revision surgery on (b)(6) 2019.We will not return at this time.
 
Event Description
Allegedly, primary surgery was performed on (b)(6) 2016.The surgeon found a dissociation after surgery and mentioned excessive stress, may have occurred during agricultural work.The surgeon performed revision surgery on (b)(6) 2019.We will not return at this time.
 
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Brand Name
COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER SHORT
Type of Device
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8758336
MDR Text Key149951838
Report Number3010536692-2019-00893
Device Sequence Number1
Product Code JDL
UDI-Device IdentifierM684260000251
UDI-PublicM684260000251
Combination Product (y/n)N
PMA/PMN Number
K004043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number26000025
Device Catalogue Number26000025
Device Lot Number1456731
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/06/2019
Date Manufacturer Received06/06/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
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