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

Model Number	EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 6734189 - 320-02-38 - rs expanded glenosphere 38mm, +4mm offset.7210419 - 320-10-10 - equinoxe reverse tray adapter plate tray +10.6259218 - 320-10-15 - humeral tray +15mm.7253808 - 320-15-05 - eq rev locking screw.7271419 - 320-20-00 - eq reverse torque defining screw kit.7271433 - 320-20-00 - eq reverse torque defining screw kit.S311116 - 320-38-00 - 145-deg pe 38mm hum liner +0.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 62 yo male patient, who had an initial rtsa on (b)(6) 2020, and had a revision procedure on (b)(6) 2022, underwent a 2nd revision procedure on (b)(6) 2024, approximately 1 year 11 months post the first revision in (b)(6) 2022.The patient did very well for about 2 years, until he recently dislocated, causing this revision.The patient was revised to a 42mm +4mm glenosphere, new locking screw, +0mm 38mm constrained liner, +15mm tray and new reverse torque screw.Fiber tape cerclage was also used around proximal humerus and tray.There were no device breakages during the procedure.There was a 30-45 minute surgical delay during the procedure with no adverse event to the patient as a result.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.No explanted devices are available for analysis as the hospital is keeping the devices.A device image was provided.No further information.The (b)(6) 2022 revision procedure was reported under mdr #1038671-2024-00546.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d4 (remove all data from initial report - catalog # unknown), d6b (remove date - unknown) g1, h4 (remove date) h6: medical device problem code, component code, investigation types, investigation findings and investigation findings.The cause of the patient¿s shoulder dislocation and subsequent revision reported cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Dislocation is a known risk, as outlined in the ifu.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 male patient, who had an initial rtsa and had a revision procedure.The patient underwent a 2nd revision procedure, approximately 1 year 11 months post the first revision.The patient did very well for about 2 years, until he recently dislocated, causing this revision.The patient was revised to a 42mm +4mm glenosphere, new locking screw, +0mm 38mm constrained liner, +15mm tray and new reverse torque screw.Fiber tape cerclage was also used around proximal humerus and tray.There were no device breakages during the procedure.There was a 30-45 minute surgical delay during the procedure with no adverse event to the patient as a result.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.No explanted devices are available for analysis as the hospital is keeping the devices.A device image was provided.No further information.

• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18927418
• Report Number: 1038671-2024-00550
• Device Sequence Number: 17287972
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/08/2026

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 Expiration Date: 09/09/2025
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• 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
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male