MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOSPHERE 42MM

Model Number 320-06-42

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/08/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 300-01-13, equinoxe, humeral stem primary, press fit 13mm; 320-42-00, equinoxe reverse 42mm humeral liner +0; 320-10-00, equinoxe reverse tray adapter plate tray +0; 320-15-01, eq rev glenoid plate.

Event Description

As reported, this (b)(6) y/o male patient¿s incurred 2 anterior dislocations.The patient was scheduled for a revision.Patient was last known to be in stable condition following the event.The patient¿s outcome is reported as resolved.All information received from a clinical study database.

Manufacturer Narrative

(h3) upon review of the available information, there is no evidence that this is a device related malfunction and there is no allegation against the device.Implantation of a total joint could result scapular notching and dislocation.The most likely cause of the reported event is patient conditions.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, this 69 y/o male patient¿s incurred 2 right shoulder anterior dislocations.The patient was scheduled for a revision.Patient was last known to be in stable condition following the event.The patient¿s outcome is reported as resolved.All information received from a clinical study database.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.(section f) please disregard f10.It were entered in error.

Event Description

As reported, this 69 y/o male patient¿s incurred 2 right shoulder anterior dislocations.The patient was scheduled for a revision.Patient was last known to be in stable condition following the event.The patient¿s outcome is reported as resolved.All information received from a clinical study database.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE
• Type of Device: GLENOSPHERE 42MM
• 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: 12868297
• MDR Text Key: 281197756
• Report Number: 1038671-2021-00638
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862563712
• UDI-Public: 10885862563712
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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: 05/10/2022

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 Model Number: 320-06-42
• Device Catalogue Number: 320-06-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White