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. CONSERVE® A-CLASS® BFH® HEAD LONG NECK 54MM; 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. CONSERVE® A-CLASS® BFH® HEAD LONG NECK 54MM; HIP COMPONENT Back to Search Results
Model Number 38AM5435
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Reaction (2414)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, pain cup neck stayed a dual mobility liner was used w/our 28mm head (right hip).Elevated ion levels and metallosis were reported in provided notes.The cup was not revised but captured as a complaint due to mom allegations.Other items not revised: profemur raz stem pyrd0008 lot 036284376, profemur modular neck pha01252 lot 046335281.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONSERVE® A-CLASS® BFH® HEAD LONG NECK 54MM
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9331092
Report Number3010536692-2019-01137
Device Sequence Number2272140
Product Code LZO
UDI-Device IdentifierM68438AM54351
UDI-PublicM68438AM54351
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K021349
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Device Explanted Year2019
Reporter Type Manufacturer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/15/2019
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 Number38AM5435
Device Catalogue Number38AM5435
Device Lot Number095271465
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/18/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/18/2019
Initial Report FDA Received Date11/15/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age71 YR
-
-