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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 PHA01232
Device Problems Corroded (1131); Device Dislodged or Dislocated (2923)
Patient Problem Unequal Limb Length (4534)
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly, the patient underwent a revision surgery due to dislocation, metal debris with pseudo-tumor formation and leg length discrepancy.Component not revised: dspcgc50 dynasty® pc shell 50mm group c lot: 129999843.
 
Manufacturer Narrative
Based on the operative notes provided for this event, the complaint primarily is against the liner and head (3010536692-2021-00038 & 3010536692-2021-00041) and there is no deficiencies stated against the neck pha01232.Please void the initial report.
 
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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
MDR Report Key11230182
MDR Text Key228679729
Report Number3010536692-2021-00039
Device Sequence Number1
Product Code LWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 02/25/2021
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
Device Operator Other
Device Model NumberPHA01232
Device Catalogue NumberPHA01232
Device Lot Number119986796
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/05/2021
Initial Date Manufacturer Received 01/05/2021
Initial Date FDA Received01/26/2021
Supplement Dates Manufacturer Received01/05/2021
Supplement Dates FDA Received02/25/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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