MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOID

Device Problems Break (1069); Component Missing (2306); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Primary surgery: (b)(6) 2015.The patient was previously revised at an unknown date.The surgeon believed the set screw was missing from the primary surgery and the glenosphere disassociated after a fall.We recently learned that the patient has a broken screw on the glenoid side of his revision.He has chosen not to seek treatment at this time.

Manufacturer Narrative

Corrections made in the following section(s): event: as reported, an x-ray verified the patient has a broken screw on the glenoid side of his left shoulder revision.The patient has chosen not to seek treatment at this time.Devices not available for evaluation, as it remains in the patient.All available information has been received at this time.

Manufacturer Narrative

Section h10: (b2) added check for hospitalization - initial or prolonged.(h3) the revision reported was likely the result of implanting the glenoid component in 40+ degrees inclination, likely due to the patient¿s poor bone quality (very little scapula remaining), which allowed for the compression screw to fracture as the glenoid component loosened.(h6) evaluation codes: 1924, 1069.Section h11: corrections made in the following section(s): (section f) please disregard f6 and f8.These were entered in error.(g3) report source should be consumer.(g4) initial awareness date in initial submission should have been 2019.

• Brand Name: EQUINOXE
• Type of Device: GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8692718
• MDR Text Key: 147881911
• Report Number: 1038671-2019-00325
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/30/2019
• Date Manufacturer Received: 11/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention