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: EXACTECH, INC. OPTETRAK ASYMMETRIC FEMORAL COMPONENT, CRUCIATE RETAINED, CEMENTED
  • 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
 

EXACTECH, INC. OPTETRAK ASYMMETRIC FEMORAL COMPONENT, CRUCIATE RETAINED, CEMENTED Back to Search Results
Catalog Number 230-03-05
Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Joint Disorder (2373)
Event Date 06/21/2018
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2017.Revision due to pain.Pending evaluation.
 
Manufacturer Narrative
Revision never took place.
 
Event Description
Revision never took place.
 
Manufacturer Narrative
Corrected information: upon investigation of this event it was found that this device was not revised.The event has been captured and appropriately reported in mfrs: 1038671-2018-00603, and 1038671-2018-00605.This device is used for treatment not diagnosis.
 
Event Description
This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00603, and 1038671-2018-00605.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OPTETRAK ASYMMETRIC FEMORAL COMPONENT, CRUCIATE RETAINED, CEMENTED
Type of Device
OPTETRAK ASYMMETRIC FEMORAL COMPONENT, CRUCIATE RETAINED, CEMENTED
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key7698246
MDR Text Key114314581
Report Number1038671-2018-00604
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number230-03-05
Was Device Available for Evaluation? No
Date Manufacturer Received04/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-