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

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.

• 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 Key: 12821296
• MDR Text Key: 285420381
• Report Number: 1038671-2021-00621
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862084521
• UDI-Public: 10885862084521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• 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 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
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 05/02/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male