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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOID, PEGGED BETA, LARGE

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EXACTECH, INC. EQUINOXE; GLENOID, PEGGED BETA, LARGE Back to Search Results
Model Number 314-02-14
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 10/26/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 300-10-15, (b)(4) - eq replicator plate 1.5mm o/s; 300-20-02, (b)(4) - eq square torque screw kit; 310-01-50, (b)(4) - eq humeral head short 50mm beta.
 
Event Description
As reported, this (b)(6) y/o male patient had a right primary total done on (b)(6) 2012.Glenoid became loose and a large central defect formed.Glenoid was removed and the defect was filled with bone autograft from clavicle.Glenoid was reamed and a hemi was performed.Patient is expected to do well and left or stable.Patient was last known to be in stable condition following the event.Devices not returning due to facility policy.
 
Manufacturer Narrative
Concomitant medical products: 300-10-15, (b)(4) - eq replicator plate 1.5mm o/s; 300-20-02, (b)(4) - eq square torque screw kit; 310-01-50, (b)(4) - eq humeral head short 50mm beta.
 
Event Description
As reported, this (b)(6) y/o male patient had a right primary total done on (b)(6) 2012.Glenoid became loose and a large central defect formed.Glenoid was removed and the defect was filled with bone autograft from clavicle.Glenoid was reamed and a hemi was performed.Patient is expected to do well and left operating room stable.Patient was last known to be in stable condition following the event.Devices not returning due to facility policy.
 
Manufacturer Narrative
(h3) the revision reported was likely the result of both patient-related conditions and a degradation of the bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision x-rays were not provided.
 
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Brand Name
EQUINOXE
Type of Device
GLENOID, PEGGED BETA, LARGE
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66 ct
gainesville FL 32653
Manufacturer Contact
kate jacobson
3523771140
MDR Report Key12821296
MDR Text Key285420381
Report Number1038671-2021-00621
Device Sequence Number1
Product Code KWT
UDI-Device Identifier10885862084521
UDI-Public10885862084521
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042021
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,Followup
Report Date 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/15/2016
Device Model Number314-02-14
Device Catalogue Number314-02-14
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2021
Initial Date FDA Received11/16/2021
Supplement Dates Manufacturer Received05/02/2022
Supplement Dates FDA Received05/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2011
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) Hospitalization; Required Intervention;
Patient Age65 YR
Patient SexMale
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