MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 13MM

Catalog Number	300-01-13
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical devices: rs glenoid plate sup aug, 10 deg (cn: 320-15-02; sn: (b)(4)); equinoxe reverse tray adapter plate tray +0 (cn: 320-10-00; sn: (b)(4)); eq reverse torque defining screw kit (cn: 320-20-00; sn: (b)(4)); equinoxe reverse 38mm humeral liner +0 (cn: 320-38-00; sn: (b)(4)); eq rev compress screw lck cap kit, 4.5 x 26mm (cn: 320-20-26; sn: (b)(4)); eq rev compress screw lck cap kit, 4.5 x 22mm (cn: 320-20-22; sn: (b)(4)); eq rev locking screw (cn: 320-15-05; sn: (b)(4)); equinoxe reverse 38mm glenosphere (cn: 320-01-38; sn: (b)(4)); eq rev compress screw lck cap kit, 4.5 x 26mm (cn: 320-20-26; sn: (b)(4)); eq rev compress screw lck cap kit, 4.5 x 22mm (cn: 320-20-22; sn: (b)(4)); eq rev compress screw lck cap kit, 4.5 x 34mm (cn: 320-20-34; sn: (b)(4)).
Event or Problem Description
The original operation was done on (b)(6) 2017.Implants need to be removed due to infection.A spacer is inserted.
Additional Manufacturer Narrative
The revision reported was likely the result of infection.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 [1].The reported infection occurred greater than 6 months after the index surgery.Therefore, neither the dhr nor the sterilization records were reviewed.1.Acute infection in total knee arthroplasty: diagnosis and treatmentjuan carlos martínez- pastor,* francisco maculé-beneyto, and santiago suso-vergaraauthor information article notes copyright and license information disclaimeropen orthop j.2013; 7: 197¿204.Published online 2013 jun 14.Superficial or deep infection are listed in the general surgical risks section of the equinoxe shoulder system ifu 700-096-060 rev.M.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL STEM PRIMARY, PRESS FIT 13MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8707422
• Report Number: 1038671-2019-00328
• Device Sequence Number: 19385936
• Product Code: KWT
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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: 300-01-13
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/30/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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: Required Intervention
• Patient Age: 73 YR