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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 02/25/2023
Event Type  Injury  
Event Description
It was reported that a patient, initial shoulder, side unknown, implanted on an unknown date, underwent a revision procedure on (b)(6) 2023, for infection.A washout was performed and the glenosphere, tray, and liner were revised.There was no device breakage or surgical delays reported.The patient was last known to be in stable condition following the event.No device returns anticipated due to the hospital policy.No further information.
 
Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
 
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Brand Name
EQUINOXE
Type of Device
PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer Contact
kate jacobson
3523771140
MDR Report Key16889646
MDR Text Key314808823
Report Number1038671-2023-00932
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/17/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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