MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-01-42
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-01-11 - equinoxe, humeral stem primary, press fit 11mm (b)(6), 320-15-01 - eq rev glenoid plate (b)(6), 320-15-05 - eq rev locking screw (b)(6) 320-20-00 - eq reverse torque defining screw kit (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6), 320-42-00 - equinoxe reverse 42mm humeral liner +0 (b)(6), 531-20-00 - shldr gps rvrs drill kit (b)(6), 531-78-20 - shouldr gps hex pins kit (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial right reverse total shoulder arthroplasty.Subsequently, it was reported that the humeral liner disassociated from the humeral tray which resulted in wear of the glenosphere and humeral tray.As a result, the patient underwent a right shoulder revision approximately 1 year and 11 months after initial implantation.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6 - type of investigation, investigation findings, investigation conclusions and h11 the revision reported was likely the result of disassembly between the humeral liner and humeral tray leading to subsequent metal-on-metal articulation between unintended components.Potential contributions to humeral liner disassembly include patient conditions, 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.However, humeral liner disassembly and prosthesis wear cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and no images or radiographs were 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 REVERSE 42MM 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24304207
• Report Number: 1038671-2026-00131
• Device Sequence Number: 12072116
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 03/18/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 320-01-42
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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: 71 YR
• Patient Sex: Male