MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-38-00

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

Patient Problem Bacterial Infection (1735)

Event Date 04/21/2016

Event Type  Injury  

Event Description

As reported, this patient entered the study, id# (b)(6) with a revision of a competitor¿s device after treatment of a deep infection on (b)(6) 2017.Initial implant date of competitor¿s device was 2009.Patient had a ¿washout¿ on (b)(6) 2016, a biopsy on (b)(6) 2016, and had a 1st sage revision on (b)(6) 2016 due to infection upon entering this study.The outcome of this event was resolved by revision on (b)(6) 2017.No further information available at this time.This is a non-valid complaint due to the revision was of competitor¿s devices.No device return anticipated due to being a clinical trial study.

Manufacturer Narrative

(h3) pending evaluation (d10) concomitant device(s): 320-01-38: equinoxe reverse 38mm glenosphere.320-10-00: equinoxe reverse tray adapter plate tray +0.300-01-07: equinoxe, humeral stem primary, press fit 7mm.320-15-02: rs glenoid plate sup aug, 10 deg.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18410415
• MDR Text Key: 331516734
• Report Number: 1038671-2023-03067
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1