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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 PHA01252
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
See investigation in 19080001.
 
Event Description
Allegedly, patient was revised due to prosthesis dislocation component not revised: tige "anca fit?" rev.Hap 1/3 proximal 15d ppr67620, lot u0780691.
 
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Brand Name
PROFEMUR MODULAR FEMORAL NECK
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 Key10230352
MDR Text Key200045052
Report Number3010536692-2020-00465
Device Sequence Number1
Product Code LWJ
UDI-Device IdentifierM684PHA012521
UDI-PublicM684PHA012521
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 07/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPHA01252
Device Catalogue NumberPHA01252
Device Lot NumberV01121543
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/02/2019
Date Manufacturer Received07/02/2019
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) Other; Required Intervention;
Patient Age70 YR
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