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. EQUINOXE; SHOULDER COMPONENTS
  • 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. EQUINOXE; SHOULDER COMPONENTS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Bone Fracture(s) (1870)
Event Date 03/01/2019
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
As reported, approximately 11 years postop this male patient¿s initial tsa, the patient was revised to a reverse tsa following 6 months of conservative treatment for a fracture.Eight months later, an infection was evident on imaging but not picked up till (b)(6).During a revision to reverse tsa on (b)(6) 2020, all implants were removed, and a second stage revision will be planned.Patient was last known to be in stable condition following the event.Devices not returned due to hospital policy.
 
Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EQUINOXE
Type of Device
SHOULDER COMPONENTS
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key9861007
MDR Text Key189055552
Report Number1038671-2020-00252
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received09/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-