MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM GLENOSPHERE

Model Number EQUINOXE REVERSE 46MM GLENOSPHERE

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

Patient Problem Osteolysis (2377)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-10-05; (b)(4); +5 adapter plate tray; 320-15-05; (b)(4); reverse locking screw; 320-20-00; (b)(4); torque defining screw kit; 320-46-13; (b)(4); reverse 46mm constrained humeral liner +2.5; 300-01-17; (b)(4); 17mm humeral stem; 320-15-02; (b)(4); 10 degree augmented glenoid plate; 320-20-22; (b)(4); 22mm screw; 320-20-34; (b)(4); 34mm screw; 320-20-38; (b)(4); 38mm screw; 320-20-38; (b)(4); 38mm screw.

Event Description

This event is the (b)(6) y/o male patient's 3rd revision surgery on right shoulder.Approximately 26 months postoperative his last revision, the patient presented with painful shoulder and warm red skin.Surgeon cultured and evidence of elevated white count was found.X-rays revealed osteolysis of proximal lateral humerus.Surgeon chose to remove old reverse implants and do a single stage hemi arthroplasty to treat patient.Surgery went well and surgeon expects a good outcome for the patient.Patient was last known to be in stable condition following the event.Device are to be returned.

Manufacturer Narrative

Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition or is nosocomial in nature.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 46MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9770502
• MDR Text Key: 189051139
• Report Number: 1038671-2020-00228
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086402
• UDI-Public: 10885862086402
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 46MM GLENOSPHERE
• Device Catalogue Number: 320-01-46
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR