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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RESURFACING CAGE, 30MM
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EXACTECH, INC. EQUINOXE; RESURFACING CAGE, 30MM Back to Search Results
Model Number RESURFACING CAGE, 30MM
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 02/19/2019
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2017.Revision due to pain.Patient had received a resurfacing hemi.Arthroplasty ¿ ream and run.
 
Manufacturer Narrative
The engineering evaluation reported this experience was likely the result of pain.Any report of pain greater than 8 months postop for the placement of a shoulder total or hemi joint is highly unlikely related to the surgical procedure for placement of the total joint or the device itself.Therefore, neither the dhr nor the sterilization records will be reviewed.Intractible pain is listed in the hemi/total joint surgery risks section of the equinoxe resurfacing system ifu 700-096-135.
 
Manufacturer Narrative
The following sections have updated info : (g4) date received by manufacturer.
 
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Brand Name
EQUINOXE
Type of Device
RESURFACING CAGE, 30MM
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key8449172
MDR Text Key139744260
Report Number1038671-2019-00174
Device Sequence Number0
Product Code KWT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 08/09/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberRESURFACING CAGE, 30MM
Device Catalogue Number312-01-02
Was Device Available for Evaluation? No
Date Manufacturer Received02/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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