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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA; HIP COMPONENT Back to Search Results
Model Number PHA0-4416
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once the investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly the biolox® liner fractured.Chip noted on femoral head, stem and shell remained intact.Liner and head were revised.Biolox® delta liner will not be returned.The following components have no alleged deficiency and were not revised during this surgery: profemur® z stem phaps236 1720674; procotyl® l shell pha06212 1717760.
 
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Brand Name
FEMORAL HEAD BIOLOX DELTA
Type of Device
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key8090216
MDR Text Key127922632
Report Number3010536692-2018-01457
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPHA0-4416
Device Catalogue NumberPHA0-4416
Device Lot Number1741019
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/01/2018
Date Manufacturer Received11/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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