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 NECK NEUTRAL SHORT COBALT CHROME; 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 NECK NEUTRAL SHORT COBALT CHROME; HIP COMPONENT Back to Search Results
Model Number PHAC1202
Medical Device Problem Codes Corroded (1131); Material Disintegration (1177)
Health Effect - Clinical Code Pain (1994)
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 elevated cobalt ion levels, pain and stiffens of the hip.It was discovered that the device failed due to corrosion of the oblong taper of modular neck where it seated in the pocked of the titanium stem.
 
Additional Manufacturer Narrative
Update lot number.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROFEMUR NECK NEUTRAL SHORT COBALT CHROME
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9716917
Report Number3010536692-2020-00115
Device Sequence Number11593257
Product Code JDL
UDI-Device IdentifierM684PHAC12021
UDI-PublicM684PHAC12021
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
K091423
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/17/2020
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 NumberPHAC1202
Device Catalogue NumberPHAC1202
Device Lot Number1647164
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/29/2020
Initial Date Received by Manufacturer 01/29/2020
Supplement Date Received by Manufacturer01/29/2020
Initial Report FDA Received Date02/17/2020
Supplement Report FDA Received Date09/17/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-