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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 PHA01254
Medical Device Problem Code Corroded (1131)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, patient was revised due to corrosion at the metal-metal junction between the cobalt-chromium modular neck and the titanium stem and the metal debris and ion cast off from the cobalt and chromium conserve femoral head and cobalt and chromium dynasty liner.Modular neck was removed and conserve femoral head was replaced with a polyethylene dual femoral head.
 
Additional Manufacturer Narrative
Corrected implant date.
 
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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 Key10362019
Report Number3010536692-2020-00549
Device Sequence Number19390286
Product Code LWJ
UDI-Device IdentifierM684PHA012541
UDI-PublicM684PHA012541
Combination Product (Y/N)N
Initial Reporter StateID
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/16/2020
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 Other
Device Model NumberPHA01254
Device Catalogue NumberPHA01254
Device Lot Number099926682
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/13/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2020
Supplement Date Received by Manufacturer07/13/2020
Initial Report FDA Received Date08/04/2020
Supplement Report FDA Received Date10/16/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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