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

Model Number	GLENOSPHERE, 36MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2022-00847
• Device Sequence Number: 4588293
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 09/15/2022; 10/19/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 10/11/2022; 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female