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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 8MM
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EXACTECH, INC. EQUINOXE PRESERVE STEM 8MM Back to Search Results
Catalog Number 300-30-08
Device Problems Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Joint Disorder (2373); No Code Available (3191)
Event Date 04/27/2018
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2018.Revision due to infection.
 
Event Description
It was reported that a patient received a total shoulder implant on (b)(6) 2018.The patient was revised on (b)(6) 2018 after an infection was diagnosed at the 4-week postop visit.The patient was stable leaving the operating room.The devices were kept by the hospital and sent to pathology.This is one of ten products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00366, 1038671-2018-00367, 1038671-2018-00369, 1038671-2018-00370, 1038671-2018-00371, 1038671-2018-00372, 1038671-2018-00373, 1038671-2018-00374 and 1038671-2018-00375.
 
Manufacturer Narrative
After further review of additional information received the following sections b4, b5, d4, g3, g4, g5, g7, h2, h4 and h6 have been updated accordingly.This device is used for treatment not diagnosis.
 
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Brand Name
EQUINOXE PRESERVE STEM 8MM
Type of Device
STEM
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key7479681
MDR Text Key107109888
Report Number1038671-2018-00368
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K162726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number300-30-08
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age84 YR
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