Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT Back to Search Results
Model Number PHA01252
Medical Device Problem Code Material Disintegration (1177)
Health Effect - Clinical Codes Pain (1994); Loss of Range of Motion (2032); Swelling (2091)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, patient underwent a revision surgery of her failed right total hip arthroplasty secondary to metal wear debris between modular components.Patient suffered persistent pain, swelling, elevated metal ions in the bloodstream, loss of mobility, and discomfort.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9645199
Report Number3010536692-2020-00084
Device Sequence Number19407088
Product Code LWJ
UDI-Device IdentifierM684PHA012521
UDI-PublicM684PHA012521
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/19/2020
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 NumberPHA01252
Device Catalogue NumberPHA01252
Device Lot Number059852601
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/13/2020
Initial Date Received by Manufacturer 01/13/2020
Supplement Date Received by Manufacturer01/13/2020
Initial Report FDA Received Date01/29/2020
Supplement Report FDA Received Date05/19/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-