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® Z STEM PLASMA SPRAYED; 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® Z STEM PLASMA SPRAYED; HIP COMPONENT Back to Search Results
Model Number PHA00264
Medical Device Problem Code Corroded (1131)
Health Effect - Clinical Code No Information (3190)
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 was revised due to corrosion at the cocr modular neck and titanium stem, elevated cobalt ions levels and loosening of the acetabular component.
 
Additional Manufacturer Narrative
Updated lot information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROFEMUR® Z STEM PLASMA SPRAYED
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9758246
Report Number3010536692-2020-00158
Device Sequence Number11464868
Product Code LPH
UDI-Device IdentifierM684PHA002641
UDI-PublicM684PHA002641
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/26/2020
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 NumberPHA00264
Device Catalogue NumberPHA00264
Device Lot Number1419582
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/07/2020
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date02/26/2020
Supplement Report FDA Received Date06/10/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-