MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; XS HUMERAL HEAD, 44MM XS OFFSET HUMERAL HEAD

Catalog Number 310-00-44

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

Patient Problem Unspecified Infection (1930)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical device(s): torque screw (cat# 300-20-02 / sn# (b)(4)); short replicator plate (cat# 300-50-45 / sn# (b)(4)); small caged glenoid (cat# 314-13-02 / sn# (b)(4)); 9mm stem (cat# 300-01-09 / sn# (b)(4)).

Event Description

It was reported that the patient had an infection.The surgeon explanted it and put in an antibiotic spacer.

Manufacturer Narrative

Section h10: (g5) pma/510(k)number: k140063.(h3) 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 infection is most likely is related to the patient¿s underlying condition.(h4) device manufacture date: 03-jan-2019.

• Brand Name: EQUINOXE
• Type of Device: XS HUMERAL HEAD, 44MM XS OFFSET HUMERAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8931954
• MDR Text Key: 156579838
• Report Number: 1038671-2019-00426
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862242594
• UDI-Public: 10885862242594
• Combination Product (y/n): N
• PMA/PMN Number: K140063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2023
• Device Catalogue Number: 310-00-44
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 82