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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID MEDIUM, BETA

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EXACTECH, INC. EQUINOXE; CAGE GLENOID MEDIUM, BETA Back to Search Results
Model Number 314-13-13
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 07/01/2021
Event Type  Injury  
Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 300-62-02, stemless humeral comp integrip, cage, size 2.310-62-47.Stemless humeral head 47mm x 15mm x beta.
 
Event Description
As reported, this (b)(6) y/o male patient¿s pain and function have been progressively worsening without injury to the right shoulder.The patient was scheduled for a revision due to glenoid loosening.Patient was last known to be in stable condition following the event.The patient¿s outcome is reported as continuing.All information received from a clinical study database.
 
Manufacturer Narrative
Section h10: (d4) serial number: (b)(6), expiration date: 04-sep-2023 (d6b) if explanted, give date: (b)(6) 2022 (h3) the revision reported was likely the result of both patient-related conditions and an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the explants and x-rays were not available for evaluation.(h4) device manufacture date: 06-sep-2018 *no information provided in the following section(s): b6, b7, c, d8, g7, h7, h9 section h11: *the following sections have corrected information: d11) concomitant device(s): 300-62-02, 6177405 - stemless humeral comp integrip, cage, size 2 310-62-47,6160794 - stemless humeral head 47mm x 15mm x beta.
 
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Brand Name
EQUINOXE
Type of Device
CAGE GLENOID MEDIUM, BETA
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 Key12868229
MDR Text Key281197175
Report Number1038671-2021-00637
Device Sequence Number1
Product Code KWT
UDI-Device Identifier10885862172693
UDI-Public10885862172693
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113309
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 04/19/2022
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 Date09/04/2023
Device Model Number314-13-13
Device Catalogue Number314-13-13
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/04/2021
Initial Date FDA Received11/24/2021
Supplement Dates Manufacturer Received03/28/2022
Supplement Dates FDA Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SEE H10
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age71 YR
Patient SexMale
Patient Weight97 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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