MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number GLENOSPHERE, 36MM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2022

Event Type  Injury  

Manufacturer Narrative

Device return anticipated.Concomitant medical products: 320-35-07, 7280058 - small superior/posterior aug glenoid plate, left; 320-20-18, s360750 - eq rev compress screw lck cap kit, 4.5 x 18mm; 320-20-26, s352725 - eq rev compress screw lck cap kit, 4.5 x 26mm; 320-15-05, 7323224 - eq rev locking screw.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 66 yo female patient, initial left shoulder implanted on (b)(6) 2022, reported feeling a pop while doing physical therapy pendulum exercises 5 months post op, and had revision surgery on (b)(6) 2022.The surgeon removed the glenoid component and converted the humeral component into a hemi.He bone grafted the glenoid with distal clavicle and will come back in to revise back to reverse after the glenoid heals.Devices are available for return.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

H6: the revision reported was likely the result of implanting two relative short screws in the inferior a/p holes of the baseplate for initial fixation, which caused the screws to converge and contact the central cage of the baseplate.This screw configuration likely prevented any biologic fixation between the bone and cage, which allowed the glenoid components to loosen and ultimately fall out of the glenoid bone.

Manufacturer Narrative

D10: serial # correction.320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm - sn-(b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm - sn - (b)(6).

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15107977
• MDR Text Key: 296658272
• Report Number: 1038671-2022-00847
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GLENOSPHERE, 36MM
• Device Catalogue Number: 320-31-36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Sex: Female