MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 38MM HUMERAL CONST LINER +2.5

Catalog Number 320-38-13

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Swelling (2091); Discharge (2225)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that a patient received a right shoulder arthroplasty on (b)(6) 2018.The patient also had a right proximal humerus fracture repaired during this initial implant procedure.On (b)(6) 2019 the patient was seen with complaints of clear yellow drainage x 2 days.States wound is red, swollen, and hot.No increase in pain.On (b)(6) 2019, the patient had an i & d for possible infection and received a downsized humeral liner from 2.5 mm constrained to 0 mm constrained.Reason for size change was not reported.Information received indicates the treatment is resolved by (b)(6) 2019.

Manufacturer Narrative

Section h10: (e3) occupation: physician.(g5) pma/510(k)number: k063569.(h3) possible wound infection.Patient states clear yellow drainage x 2 days.States wound is red, swollen and hot.No increase in pain.Seen by one of dr.Parada's colleagues to rule out infection.Scheduled for i & d for possible infection same day.Downsized humeral liner from 2.5 mm constrained to 0 mm constrained.The case report form indicates this event is unlikely related to devices and possibly related to procedure.This event report was received through clinical data collection activities.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the fracture during the implant procedure is most likely is related to the patient¿s underlying condition of infection.No information provided in the following section(s): b6, b7, g8, h4, h6, h7 section h11: corrections made in the following section(s): (section f) please disregard f6 and f8.These were entered in error.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 38MM HUMERAL CONST LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8912213
• MDR Text Key: 155030394
• Report Number: 1038671-2019-00412
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086686
• UDI-Public: 10885862086686
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-38-13
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/08/2019
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 123