MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL LINER +2.5

Model Number 320-42-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation concomitant device(s): 300-01-13, equinoxe, humeral stem primary, press fit 13mm.320-10-00, equinoxe reverse tray adapter plate tray +0.320-01-42, equinoxe reverse 42mm glenosphere 320-15-02, rs glenoid plate sup aug, 10 deg.

Event Description

As reported, this (b)(6) y/o male patient is approximately 3 weeks postop the initial implant was returned to surgery for evacuation of a large hematoma at the level of the scar and for joint lavage without revision of the prosthesis + antibiotic treatment in coordination with the infectious diseases department of the hospital.Patient was last known to be in stable condition following the event.The device will not be returned due to study policy.

Manufacturer Narrative

Section h10: (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.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM HUMERAL LINER +2.5
• 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: 12478218
• MDR Text Key: 271686111
• Report Number: 1038671-2021-00479
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-42-03
• Device Catalogue Number: 320-42-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 104 KG