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

Model Number	EQUINOXE REVERSE 46MM GLENOSPHERE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: REVERSE 46MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9770502
• Report Number: 1038671-2020-00228
• Device Sequence Number: 3153587
• Product Code: KWT
• UDI-Device Identifier: 10885862086402
• UDI-Public: 10885862086402
• Combination Product (Y/N): N
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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 Model Number: EQUINOXE REVERSE 46MM GLENOSPHERE
• Device Catalogue Number: 320-01-46
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR