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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 PHA01202
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Investigation completed.Evaluation codes added.
 
Event or Problem Description
Allegedly, patient was revised due to prosthesis dislocation.Components not revised: cotyle "anca" avec trous a/revet.Hap 62 ppr67262 lot s07108479.Tige "anca fit?" rev.Hap 1/3 proximal 11g ppr67606 lot s07108935.Noyau "anca fit?"10 deg.62*28 ppr67562 lot s06108481.
 
Additional Manufacturer Narrative
Evaluation codes updated.- attachment: [19070916fdatimingletterupdates.Pdf].
 
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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 Key10257641
Report Number3010536692-2020-00475
Device Sequence Number11491170
Product Code LWJ
UDI-Device IdentifierM684PHA012021
UDI-PublicM684PHA012021
Combination Product (Y/N)N
Initial Reporter CountryIT
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2003
Device Explanted Year2003
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/10/2020
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 NumberPHA01202
Device Catalogue NumberPHA01202
Device Lot NumberT03121744
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/02/2019
Initial Date Received by Manufacturer 07/02/2019
Supplement Date Received by Manufacturer07/02/2019
Initial Report FDA Received Date07/10/2020
Supplement Report FDA Received Date07/10/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
Patient Age65 YR
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