MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 12MM

Model Number	EQUINOXE PRESERVE STEM 12MM
Health Effect - Clinical Codes	Unspecified Infection (1930); Impaired Healing (2378)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: equinoxe square torque defining screw drive kit (cn: 300-20-02; sn: (b)(4)); equinoxe replicator plate, 1.5mm o/s (cn: 300-10-15; sn: (b)(4)); equinoxe cage glenoid xl, post aug, right (cn: 314-13-35; sn: (b)(4)); equinoxe humeral head, short, 53mm (beta) (cn: 310-01-53; sn: (b)(4)).
Event or Problem Description
Index surgery: 2018.Patient's right shoulder did not heal properly, and a later arthroscopic surgery could not repair it and it became infected.Patient needs surgery to remove the metal and install an antibiotic spacer.
Additional Manufacturer Narrative
Section h10: (d4) expiration date: 12-aug-2028 (e3) occupation: physician (e4) no (g5) pma/510(k)number: k162726 (h3) the patient reported that initial surgery to the right shoulder surgery in 2018 did not heal properly and a later arthroscopic surgery could not repair it and it became infected.Surgery to remove the metal and install an antibiotic spacer was completed due to the infection.After the infection clears, a reverse replacement on the right side will be scheduled.This device is used for treatment not diagnosis.Device specific risks - fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.Infection is a known risk in any total joint surgery.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 event of infection is greater than 3 months postop and it is highly unlikely to be related to the surgical procedure or devices.The most likely cause of the reported event is related to the underlying patient condition.This cannot be determined as devices were not returned for investigation.(h4) 13-aug-2018 no information provided in the following section(s): a4, a5, b6, b7, d6, g8, 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 PRESERVE STEM 12MM
• Common Device Name: EQUINOXE PRESERVE STEM 12MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8649586
• Report Number: 1038671-2019-00295
• Device Sequence Number: 11518190
• Product Code: KWT
• UDI-Device Identifier: 10885862515803
• UDI-Public: 10885862515803
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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 Model Number: EQUINOXE PRESERVE STEM 12MM
• Device Catalogue Number: 300-30-12
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/03/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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