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

Model Number	314-02-14
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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.

• Brand Name: EQUINOXE
• Common Device Name: 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 Key: 12821296
• Report Number: 1038671-2021-00621
• Device Sequence Number: 4906222
• Product Code: KWT
• UDI-Device Identifier: 10885862084521
• UDI-Public: 10885862084521
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2016
• Device Model Number: 314-02-14
• Device Catalogue Number: 314-02-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male