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

Catalog Number	310-00-44
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient had an infection.The surgeon explanted it and put in an antibiotic spacer.
Additional 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
• Common Device Name: XS HUMERAL HEAD, 44MM XS OFFSET HUMERAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8931954
• Report Number: 1038671-2019-00426
• Device Sequence Number: 2047928
• Product Code: KWT
• UDI-Device Identifier: 10885862242594
• UDI-Public: 10885862242594
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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 Expiration Date: 12/30/2023
• Device Catalogue Number: 310-00-44
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 82