MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SMALL PROX BODY +12.5

Model Number	308-09-12
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 25mm middle segment modular (cat# 308-10-25 / sn# (b)(4)), taper locking screw 37.5 (cat# 308-15-37 / sn# (b)(4)), equinoxe reverse 38mm glenosphere (cat# 320-01-38 / sn# (b)(4)), equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / sn# (b)(4)), equinoxe rev locking screw (cat# 320-15-05 / sn# (b)(4)), equinoxe rev torque screw (cat# 320-20-00 / sn# (b)(4)) , equinoxe reverse 38mm humeral liner +0 (cat# 320-38-00 / sn# (b)(4)).
Event or Problem Description
It was reported that the original right shoulder surgery for this female pt was done on (b)(6) 2018 by another surgeon at (b)(6).The surgeon implanted the exact same sizes of all items that had been removed.He decided to do this case because the patient was believed to be infected.The surgeon opened the joint in standard fashion.He then took out all modular implants and cleaned out the joint to get rid of infection.Then he replaced the implants that he took out and closed the joint in standard fashion.The patient left the or in stable condition and is expected to have a good outcome.
Additional Manufacturer Narrative
Corrections made in the following section(s): updated serial number for equinoxe reverse 38mm humeral liner +0 (cat# 320-38-00 / sn# (b)(4)).
Event or Problem Description
As reported, the initial right tsa for this older female patient was on (b)(6) 2018.On (b)(6) 2019, a revision was completed due to probable infection.The surgeon took out all modular implants and cleaned out the joint to get rid of infection.The implants that were removed were replaced with the exact same sizes of all items that had been removed.The patient left the or in stable condition and is expected to have a good outcome.Hospital did not release implants to be returned.All available information has been received at this time.
Additional Manufacturer Narrative
Section h10: (h3) as reported, the initial right tsa for this older female patient was on (b)(6) 2018.On (b)(6) 2019, a revision was completed due to probable infection.The surgeon took out all modular implants and cleaned out the joint to get rid of infection.The implants that were removed were replaced with the exact same sizes of all items that had been removed.The patient left the or in stable condition and is expected to have a good outcome.Hospital did not release implants to be returned.All available information has been received at this time.Any ¿surgical site¿ infection noted in a patient that is greater than 3 months postop from a total joint surgical procedure is highly unlikely to be related to the surgical procedure for placement of the total joint or the device itself.(ref 1) it is noted that surgical intervention or revision along with infection is a known risk in any total joint surgery and may result in revision.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision, cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Reference: 1.Acute infection in total knee arthroplasty: diagnosis and treatment juan carlos martínez-pastor,* francisco maculé-beneyto, and santiago suso-vergara author information article notes copyright and license information disclaimer open orthop j.2013; 7: 197¿204.Published online 2013 jun 14.Section h11: *the following sections have corrected information: (b5) as reported, the initial right tsa for this older female patient was on (b)(6) 2018.On (b)(6) 2019, a revision was completed due to probable infection.The surgeon took out all modular implants and cleaned out the joint to get rid of infection.The implants that were removed were replaced with the exact same sizes of all items that had been removed.The patient left the or in stable condition and is expected to have a good outcome.Hospital did not release implants to be returned.All available information has been received at this time.*no information provided in the following section(s): a2, a4, a5, b6, b7, g8, h7, h9.

• Brand Name: EQUINOXE
• Common Device Name: SMALL PROX BODY +12.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9156019
• Report Number: 1038671-2019-00482
• Device Sequence Number: 2774486
• Product Code: KWT
• UDI-Device Identifier: 10885862273178
• UDI-Public: 10885862273178
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K143659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2020

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: 308-09-12
• Device Catalogue Number: 308-09-12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 09/17/2019; 03/09/2020
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/17/2019; 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention