MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 11X80MM DISTAL STEM MODULAR CEMENTED

Catalog Number 308-01-11

Device Problems Loose or Intermittent Connection (1371); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): distal stem collar (cat# 308-05-26 / sn# (b)(4)), 0 mm proximal body large (cat# 308-10-05 / sn# (b)(4)), taper locking screw (cat# 308-15-01 / sn# (b)(4)), humeral adapter tray +0 (cat# 320-10-00 / sn# (b)(4)), torque defining screw kit (cat# 320-20-00 / sn# (b)(4)), 42 mm constrained humeral liner +0 (cat# 320-42-10 / sn# (b)(4)), 42 mm expanded geosphere +4 mm (cat# 320-02-42 / sn# (b)(4)), geosphere locking screw (cat# 320-15-05 / sn# (b)(4)), sup/post augment glenoid plate right (cat# 320-15-08 / sn# (b)(4)), compression screw 22 mm (cat# 320-20-22 / sn# (b)(4)), compression screw 22 mm (cat# 320-20-22 / sn# (b)(4)), compression screw 26 mm (cat# 320-20-26 / sn# (b)(4)), compression screw 26 mm (cat# 320-20-26 / sn# (b)(4)) , compression screw 30 mm (cat# 320-20-30 / sn# (b)(4)) , cement restrictor (cat# tpa-18 / sn# (b)(4)).

Event Description

As reported, approximately 9 years and 3 months post right shoulder implant, the patient had an acute event where the glenoid component and geosphere came away from the bone.Many attempts at rescheduling a revision were made and, on this day, she came in for a revision arthroplasty.The surgeon planned on putting our largest humeral head onto her hrp humeral side, but during surgery her glenoid bone was so small and other major structures (coracoid/acromium) were virtually gone.Surgeon was concerned the big ball hemi would not be contained without this ceiling so opted to remove the humeral side hrp along with everything that was loose from the glenoid, leave patient without any implants and a resection arthroplasty for pain relief purposes.Patient left the operating room in stable condition.There was no delay to the surgery.There was no reported patient injury.

Manufacturer Narrative

The revision reported was likely the result of the patient¿s poor bone quality which allowed for the glenoid components to loosen.Device manufacture date: 21-feb-2017.

• Brand Name: EQUINOXE
• Type of Device: 11X80MM DISTAL STEM MODULAR CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9069464
• MDR Text Key: 162264093
• Report Number: 1038671-2019-00450
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862267917
• UDI-Public: 10885862267917
• Combination Product (y/n): N
• PMA/PMN Number: K143659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 308-01-11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention