MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-01-46
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient had a right reverse shoulder put in 2020.Revised again in 2021 by a local orthopedic surgeon.Then patient saw a different surgeon who revised the patient and took out humeral components and glenosphere and replaced.There was a lot of matellosis and the tray was completely sheered off the stem.The stem had overstuffed the joint, a 15 preserve stem was used.The surgeon could not find the liner poly from the original surgery.Surgeon checked around the joint for it as well as his pa and assist.No one could feel for the 46 +2.5mm liner in the joint.Patient was revised to a fx stem and a new glenosphere and tray and liner.Patient was last known to be in stable condition following the event.Photos, x-rays, and ebi attached.Product not returning: risk manager at this facility will not release implants to me.Only release to patient.But i do have pictures.300-30-15 equinoxe preserve stem 15mm (b)(6).Udi number (b)(4).510(k) number k162726.Product code phx, kws, hsd, kwt.320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6).Udi number (b)(4).510(k) number k063569.Product code kwt.320-46-03 - 145-deg pe 46mm hum liner +2.5 (b)(6).Udi number (b)(4).510(k) number k063569.Product code kwt.Recall number z-1424-2024.320-01-46 - equinoxe reverse 46mm glenosphere (b)(6).Udi number (b)(4).510(k) number k063569.Product code kwt.Concomitants: 320-15-01 - eq rev glenoid plate (b)(6).320-20-00 - eq reverse torque defining screw kit (b)(6).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).321-20-00 - equinoxe reverse shoulder drill kit (b)(6).320-15-05 - eq rev locking screw (b)(6).
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): 320-15-01 - eq rev glenoid plate (b)(6).320-20-00 - eq reverse torque defining screw kit (b)(6).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).321-20-00 - equinoxe reverse shoulder drill kit (b)(6).320-15-05 - eq rev locking screw (b)(6).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported was likely due to disassembly between the humeral liner and humeral tray leading to subsequent unintended metal-on-meal articulation between components.However, migration of the liner subsequent to the disassembly, and the sequence of events could not be confirmed.Potential contributions of user and patient-related considerations to the event, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the disassembly of the humeral liner cannot be confirmed from the reported information, as the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE REVERSE 46MM GLENOSPHERE
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20351873
• Report Number: 1038671-2024-03784
• Device Sequence Number: 7926583
• Product Code: KWT
• UDI-Device Identifier: 10885862086402
• UDI-Public: 10885862086402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 09/22/2025

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?: Yes
• Device Expiration Date: 06/15/2021
• Device Catalogue Number: 320-01-46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male