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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT Back to Search Results
Model Number PHA0-1254
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly the patient was revised due to mom complications.Left.Update 10/09/2019: instructed dr davis that the current neck need to come out due to possible failure neck would not come out the instruments that we had both dr davis chuck tried to extract it.I told them to stop because we could break the extracting device for got trials liners so they wasted one strecker dual mobility liner was used with our head.
 
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Brand Name
PROFEMUR MODULAR FEMORAL NECK
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10082995
Report Number3010536692-2020-00372
Device Sequence Number776468
Product Code LWJ
UDI-Device IdentifierM684PHA012541
UDI-PublicM684PHA012541
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberPHA0-1254
Device Catalogue NumberPHA0-1254
Device Lot Number096376582
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/15/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/15/2019
Initial Report FDA Received Date05/22/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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