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 A/R 8DG 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 A/R 8DG SHORT COBALT CHROME; HIP COMPONENT Back to Search Results
Model Number PHAC1232
Medical Device Problem Codes Corroded (1131); Insufficient Device Problem Information (3190)
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 unknown reasons.Left hip.
 
Event or Problem Description
Allegedly patient was revised due to unknown reasons.Left hip.Updated information on 03/16/2020: allegedly, the patient was revised due to corrosion of cocr components.
 
Additional Manufacturer Narrative
Updated information on 03/16/2020: allegedly, the patient was revised due to corrosion of cocr components.Updated event codes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROFEMUR® NECK A/R 8DG SHORT COBALT CHROME
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9555125
Report Number3010536692-2020-00021
Device Sequence Number19698397
Product Code JDL
UDI-Device IdentifierM684PHAC12321
UDI-PublicM684PHAC12321
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K091423
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/21/2020
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 NumberPHAC1232
Device Catalogue NumberPHAC1232
Device Lot Number1702505
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/09/2019
Initial Date Received by Manufacturer 12/09/2019
Supplement Date Received by Manufacturer12/09/2019
Initial Report FDA Received Date01/06/2020
Supplement Report FDA Received Date05/21/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-