MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-01-38
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Study: equinoxe shoulder study subject: (b)(6).Date of event onset : 12-14-2021 adverse event name : disassociation of glenosphere briefly describe adverse event : the patient following a right hemilated hemorrhagic stroke in 2019 reports pain and functional impotence serious adverse event? : yes ae related to device? : definitely not related ae related to procedure? : definitely not related no action taken.Outcome is unknown stating the patient refuses preothesis revision surgery.320-01-38 - equinoxe reverse 38mm glenosphere 510k: k063569 concomitants: 300-01-15 - equinoxe, humeral stem primary, press fit 15mm 320-38-00 - equinoxe reverse 38mm humeral liner +0 320-10-00 - equinoxe reverse tray adapter plate tray +0 320-15-04 - rs glenoid plate r post aug, 8 deg, right 73 yo white male height: 165 cm weight: 70 kgs bmi: 26 diagnosis: rotator cuff arthropathy comorbidities: hypertension.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 300-01-15 - equinoxe, humeral stem primary, press fit 15mm 320-38-00 - equinoxe reverse 38mm humeral liner +0 320-10-00 - equinoxe reverse tray adapter plate tray +0 320-15-04 - rs glenoid plate r post aug, 8 deg, right.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5, e1, g1, h6.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
Approximately 5 year(s), 2 month(s) and 11 day(s) post-operative of a right rtsa, it was reported via clinical study that the patient experienced disassociation of glenosphere.The patient, following a right hemilated hemorrhagic stroke 2 years prior, reports pain and functional impotence.The patient was given medication and refuses prosthesis revision surgery, so the outcome of this event is unknown.The case report form indicates that this event is definitely not related to the device(s) and/or to the procedure.This was reported through clinical trial study data collection activities, no device return is anticipated, and no other information is available at this time.
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.Operative notes and/or medical records were not provided for review of usage/ technique.The glenosphere disassociation reported was likely the result of disassembly between the glenoid locking screw and the baseplate.However, the failure cannot be confirmed as the devices remain implanted and no clinical imaging was provided.Contributions of the patient-related issues, manufacturing-related considerations, or user-related considerations to the reported event cannot be determined from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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 38MM 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 ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18518988
• Report Number: 1038671-2024-00093
• Device Sequence Number: 15122390
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K06356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/04/2025

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: 320-01-38
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 01/27/2025; 02/26/2025; 02/26/2025
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 01/27/2025; 03/26/2025; 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 H10
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White