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

Catalog Number	320-38-13
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Swelling (2091); Discharge (2225)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem 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.
Additional 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
• Common Device Name: EQUINOXE REVERSE 38MM HUMERAL CONST LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8912213
• Report Number: 1038671-2019-00412
• Device Sequence Number: 205640
• Product Code: KWT
• UDI-Device Identifier: 10885862086686
• UDI-Public: 10885862086686
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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 Catalogue Number: 320-38-13
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 123