MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; STANDARD HUMERAL STEM

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.Pending evaluation.Concomitant medical devices: humeral tray.Torque screw.Humeral liner.Glenosphere.Glenosphere locking screw.Glenoid baseplate.

Event Description

Index surgery: (b)(6) 2014.Revision due to infection.The patient dislocated and spun his humeral implant loose.The patient has a spacer now.The case report form indicates this event is definitely not related to devices and definitely related to procedure.

Manufacturer Narrative

(b2) outcomes attributed to adverse event : added check for hospitalization - initial or prolonged.(e3) occupation: physician.(g3) report source: health professional.(h3) the revision reported was likely the result of infection.According to the information provided, the patient also experienced loosening, dislocation, and pain, which were likely due to the reported infection.The reported event was a revision due to 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 treatment (b)(6).Open 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.(h6) evaluation codes: 1735, 2993.Section h11: corrections made in the following section(s): (section f) please disregard f6 and f8.These were entered in error.(g4) initial awareness date in initial submission should have been 08-jun-2019.

• Brand Name: EQUINOXE
• Type of Device: STANDARD HUMERAL STEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8756337
• MDR Text Key: 149911992
• Report Number: 1038671-2019-00353
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/08/2019
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 87