MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-46-03
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this male patient presented with a left exactech reverse shoulder with a dissociated humeral poly component.Patient did not report any traumatic event.Dissociated poly was removed along with the adapter tray, glenosphere, and locking screws for each.A lateralized glenosphere was implanted as well as a +5 tray and +0 liner.No adverse event as a result.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, d6a, h4, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported may have been due to disassembly between the humeral liner and humeral tray.However, the reported disassembly cannot be confirmed.Additionally, potential contributions from patient conditions, 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 returned for evaluation and images/radiographs were not provided.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.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 46MM HUMERAL LINER +2.5
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15536718
• Report Number: 1038671-2022-01231
• Device Sequence Number: 6972170
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2025

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 Expiration Date: 07/05/2025
• Device Model Number: 320-46-03
• Device Catalogue Number: 320-46-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 04/30/2025; 04/30/2025
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 05/01/2025; 05/01/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 79 KG