MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 6MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-30-06
Medical Device Problem Codes	Unstable (1667); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Subluxation (4525); Joint Laxity (4526)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 53 yo male patient, initial left shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2024, approximately 11 months post the initial procedure.The patient was revised due to shoulder pain and instability.Once patient was opened up, it was noticeable that the poly was flattened down quite a bit, and that the patient had been subluxing for a while due to his shoulder being loose.The stem was well fixated and left in place.The stem did subside a little bit.Poly was distorted from subluxation.Patients +0 mm tray and 42mm +0 liner were replaced with a +10 mm tray and 42mm +0 liner.The humeral implants were replaced except for the stem.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.The explanted devices are not available for return as the hospital won¿t release them.No x-rays or device images were able to be obtained.No further information.
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 320-06-42 - glenosphere 42mm; (b)(6), 320-15-01 - eq rev glenoid plate; (b)(6), 320-15-05 - eq rev locking screw; (b)(6), 320-20-00 - eq reverse torque defining screw kit; (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm; (b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm; (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; (b)(6), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b2, b5, d1, h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported may have been due to instability and dislocation, which likely led to deformation of the humeral liner and the patient¿s reported pain.It is unclear whether the humeral liner nonconformance issue may have contributed to dislocation and/or deformation.However, these failures, the sequence of events, and the underlying cause cannot be confirmed because the revised components were not returned for evaluation, and no images or radiographs were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a male patient had an initial left shoulder implanted and then underwent a revision procedure, approximately 11 months post the initial procedure.The patient was revised due to shoulder pain and instability.Once patient was opened up, it was noticeable that the poly was flattened down quite a bit, and that the patient had been subluxing for a while due to his shoulder being loose.The stem was well fixated and left in place.The stem did subside a little bit.Poly was distorted from subluxation.Patients +0 mm tray and 42mm +0 liner were replaced with a +10 mm tray and 42mm +0 liner.The humeral implants were replaced except for the stem.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.The explanted devices are not available for return as the hospital won¿t release them.No x-rays or device images were able to be obtained.No further information.

• Brand Name: EQUINOXE PRESERVE STEM 6MM
• 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 ; 3525541928
• MDR Report Key: 21642059
• Report Number: 1038671-2025-01614
• Device Sequence Number: 7700887
• Product Code: KWT
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 12/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 300-30-06
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 12/17/2025
• Date Device Manufactured: 11/18/2022
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male