MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-11
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-10-15 - equi replicator plate 1.5mm o/s: (b)(6), 300-20-02 - equi sq torqe define screw drive kit: (b)(6), 310-01-47 - equi, hume head short, 47mm (beta): (b)(6), 314-13-24 - equi cage glenoid l, post aug, left: (b)(6).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, who had a left anatomic shoulder replacement, underwent a revision procedure approximately 3 years 4 months post the initial procedure.During the humeral head removal step, the insitu humeral stem came out.Subsequently a full revision was performed replacing all implants.There were no complications for the patient.No x-rays were able to be obtained.The explanted device is not available for return as it was discarded.This is 1 of 2 events for this patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, radiograph images were not provided for review.A review of complaint history determined that no further action is required as no trends were identified.Device image was reviewed.The explanted humeral stem appeared to have remnants of blood and bone on the explanted stem, which is consistent with an explanted device.All other aspects appeared unremarkable.The cause of the humeral loosening reported cannot be conclusively determined, but may be related to inadequate initial fixation, mechanical loss of fixation over time, stress shielding, or biologic loss of fixation caused by particle-induced osteolysis around the implant.However, this cannot be confirmed and contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and no radiographs were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: 23689088
• Report Number: 1038671-2025-03470
• Device Sequence Number: 13310099
• Product Code: KWS
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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 Catalogue Number: 300-01-11
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Male