MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOSPHERE 38MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-06-38
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); Metal Related Pathology (4530); Solid Tumour (4552); Implant Pain (4561)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial reverse total shoulder replacement on the right side and was implanted with exactech devices.Subsequently, the patient experienced a dislocation.Patient had spine surgery and has had shoulder pain since.Physical therapy was ordered for strengthening exercises.Shoulder became easily aggravated, so ct ordered.Ct completed showing dislocation.X-rays done confirming dislocation w/ possible dissociation of polyethylene liner from humeral tray during patient office visit.As a result, approximately 1 after initial replacement, the patient underwent a right shoulder revision.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
(d10) concomitant devices: 320-38-00 - 145-deg pe 38mm hum liner +0: s109676; 300-01-15 - eq humeral stem primary, press fit 15mm: 6597110; 320-10-00 - equinoxe reverse adapter plate tray +0: 6676606; 320-15-04 - rs glenoid plate r post aug, 8 deg, right: 5276547; 320-15-05 - eq rev locking screw: 6666160.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was unable to be performed as the lot information of the product involved in the event was not available.A review of complaint history was unable to be performed as the relevant device and event information was unknown.The revision reported was likely due to dislocation and disassembly between the liner and humeral tray.This likely led to wear between the humeral tray and glenosphere, leading to the reported metallosis.However, the reported dislocation, disassembly, and prosthesis wear 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 reported disassembly of the humeral liner cannot be determined as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE GLENOSPHERE 38MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22756482
• Report Number: 1038671-2025-02713
• Device Sequence Number: 18560062
• Product Code: PHX
• UDI-Device Identifier: 10885862563699
• UDI-Public: 10885862563699
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320-06-38
• 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: 02/21/2024
• Initial Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 06/29/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White