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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 PHA01212
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code Unequal Limb Length (4534)
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, the patient was revised due to leg length discrepancy of about 4mm on the right side.Radiographic images showed possible loosening of cup and stem.The revision was scheduled to replace the head and neck and possibly the liner.When trying to remove the neck from the stem, it could not be separated.So the stem was also removed.Additional information received on 02/02/2021: revised part and lot numbers were provided as well as the reason for revision, moreover the revision surgery 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 Key11357805
Report Number3010536692-2021-00095
Device Sequence Number16322412
Product Code LWJ
UDI-Device IdentifierM684PHA012121
UDI-PublicM684PHA012121
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/21/2021
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 NumberPHA01212
Device Catalogue NumberPHA01212
Device Lot Number079905029
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/02/2021
Initial Date Received by Manufacturer 02/02/2021
Supplement Date Received by Manufacturer02/02/2021
Initial Report FDA Received Date02/22/2021
Supplement Report FDA Received Date04/21/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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