MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE 38MM GLENOSPHERE
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	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products - eq rev locking screw (cat# 320-15-05 / serial# (b)(6) - equinoxe reverse 38mm humeral liner +2.5 (cat# 320-38-03 / serial# (b)(6) - equinoxe reverse tray adapter plate tray +5 (cat# 320-10-05 / serial# (b)(6) - eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported approximately one month post initial right tsa, the 59 y/o female patient had a revision due to dislocation.Surgeon exchanged the glenosphere, liner and adapter tray.New devices included a +4mm, 42mm glenosphere, constrained liner and a +10mm adapter tray.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or images.The devices are not available for evaluation as they were disposed by the hospital staff.
Additional Manufacturer Narrative
Section h10: (h3) upon review of the available information, there is no evidence that this is a device related malfunction and there is no allegation against the device.Implantation of a total joint could result scapular notching and dislocation.The most likely cause of the reported event is patient conditions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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 and/or subluxation are known risks, 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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 and/or subluxation are known risks, 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.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• 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: kate jacobson
• MDR Report Key: 17612127
• Report Number: 1038671-2023-02037
• Device Sequence Number: 6631650
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/27/2025

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 Model Number: EQUINOXE REVERSE 38MM GLENOSPHERE
• 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: 08/07/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 03/16/2025; 03/16/2025
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 04/18/2024; 03/27/2025; 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM; EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female