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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 PHA01244
Device Problems Corroded (1131); Naturally Worn (2988)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once the investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly the patient was revised due to osteolysis (right hip) metal on metal construct (revision) modular neck and head were exchanged for new product.Dr.Would like neck tested for wear and corrosion due to osteolysis in the femur surrounding the implant.The following components have no alleged deficiency and were not revised during this surgery: lineage® acetabular shell (b)(4); profemur® plasma z stem (b)(4).
 
Event Description
Allegedly the patient was revised due to osteolysis (right hip) metal on metal construct (revision) modular neck and head were exchanged for new product.Dr.Would like neck tested for wear and corrosion due to osteolysi.
 
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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 Key8052979
MDR Text Key126630720
Report Number3010536692-2018-01423
Device Sequence Number1
Product Code LWJ
Combination Product (y/n)N
PMA/PMN Number
K003016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/03/2020
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
Device Operator Other
Device Model NumberPHA01244
Device Catalogue NumberPHA01244
Device Lot NumberT11134696
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/10/2018
Initial Date Manufacturer Received 10/10/2018
Initial Date FDA Received11/08/2018
Supplement Dates Manufacturer Received10/10/2018
Supplement Dates FDA Received02/03/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient Weight103
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