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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
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to prosthesis dislocation component not revised : cotyle "anca" avec trous a/revet.Hap 52 ppr67252, lot v0284973.Noyau "anca fit?"10 deg.52*28 ppr67552, lot u0265520.
 
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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 Key9922286
MDR Text Key186561530
Report Number3010536692-2020-00317
Device Sequence Number1
Product Code LWJ
UDI-Device IdentifierM684PHA012541
UDI-PublicM684PHA012541
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPHA01254
Device Catalogue NumberPHA01254
Device Lot NumberV05185862
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/02/2019
Date Manufacturer Received02/07/2019
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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