MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-03
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Subluxation (4525)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 0 year(s) and 7 month(s) post implantation of left (second) revised tsa (revisions reported on (b)(4), the patient presented with polyethylene wear with or without osteolysis.Patient has history of subluxations since second revision suggesting wear of the polyethylene.The patient reports regular subluxation episodes at a post op visit 7 months after above reported event.The patient has adapted his activities and avoids any forced movement.Patient was seen approximately 1 year and 3 months later and was last reported in stable condition.The outcome of the event is continuing and the clinical report indicates that the event is definitely not related to the device(s) and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-02-38 - rs expanded glenosphere 38mm, +4mm offset: (b)(6), 320-10-05 - equinoxe reverse tray adapter plate tray +5: (b)(6), 320-15-05 - eq rev locking screw: (b)(6), 320-20-00 - eq reverse torque defining screw kit: (b)(6).
Additional Manufacturer Narrative
After review of information received and the completion of investigation, the following sections g1, g3, g6, h1, h2, h3 and h6 have been updated accordingly.(h3): the event reported may have been due to prosthesis wear and subluxation.The sequence of the reported events cannot be confirmed; however, the reported subluxations may have contributed to the reported wear.The wear and subluxation cannot be confirmed as the device was not returned for evaluation as it remains implanted at this time and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-1418-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The event reported may have been due to prosthesis wear and subluxation.The sequence of the reported events cannot be confirmed; however, the reported subluxations may have contributed to the reported wear.The wear and subluxation cannot be confirmed as the device was not returned for evaluation as it remains implanted at this time and 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.

• Brand Name: EQUINOXE REVERSE 38MM 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19581668
• Report Number: 1038671-2024-02061
• Device Sequence Number: 17989946
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 01/14/2025

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: 09/03/2024
• Device Catalogue Number: 320-38-03
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 10/30/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 11/05/2024; 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 101 KG