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

Model Number 320-01-42

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 01/02/2020

Event Type  Injury  

Manufacturer Narrative

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.Concomitant device(s): 300-30-07, equinoxe preserve stem 7mm 320-42-03, equinoxe reverse 42mm humeral liner +2.5 320-10-00, equinoxe reverse tray adapter plate tray +0 320-15-04, rs glenoid plate r post aug, 8 deg, right.

Event Description

As reported, approximately 3 months postoperatively, this (b)(6) y/o male patient presented with a superficial infection and mild swelling around medial incision of the right shoulder.The patient was treated with medication.The right shoulder was revised 2 months later with and irrigation & debridement.The patient was dismissed home 2 days postop.The devices will not return due to study policy.The patient has a history of osteoarthritis, hypertension and gout.The case report form indicates this event is unlikely related to devices and possibly related to the procedure.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM GLENOSPHERE
• 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: 11463925
• MDR Text Key: 249814300
• Report Number: 1038671-2021-00105
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-01-42
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: No
• 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 Weight: 79