• 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 VAR/VAL 8DG LONG 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 VAR/VAL 8DG LONG COBALT CHROME; HIP COMPONENT Back to Search Results
Model Number PHAC1254
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 06/30/2023
Event Type  Injury  
Event Description
Allegedly, uncoupling of the femoral stem at the neck (neck-stem junction) without associated trauma (unexpected rupture).Need for revision surgery with complete replacement of the prosthetic assembly.
 
Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME
Type of Device
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
rachael wise
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key17644003
MDR Text Key322202386
Report Number3010536692-2023-00156
Device Sequence Number1
Product Code JDI
UDI-Device IdentifierM684PHAC12541
UDI-PublicM684PHAC12541
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K091423
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/29/2023
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
Device Operator Health Professional
Device Model NumberPHAC1254
Device Catalogue NumberPHAC1254
Device Lot Number1438244
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/09/2023
Initial Date FDA Received08/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-