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 Codes	Unspecified Infection (1930); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	09/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-10-45 - equi replicator plate 4.5mm o/s: (b)(6), 300-20-02 - equi square torque define screw drive kit: (b)(6), 310-01-50 - equi, humeral head short, 50mm (beta): (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 73 yo male patient, who had a right tsa, underwent a revision procedure approximately 6 years 4 months post the initial procedure.The patient was indicated for surgery due to possible infection/metalosis.Upon exposure, puss was noted surrounding the humeral implants, with significant bone loss of the medial calcar.Humeral implant was loose and easily explanted.Glenoid implant was no longer fixated.The polyethylene component of the glenoid implant had disassociated from the central metal cage, which had fragmented.There was severe bone loss in the glenoid.All components where explanted, and a cement spacer was implanted.There was device breakage, the glenoid central cage had fragmented.All parts and pieces were removed.There were no surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available for return.The hospital retained them for analysis.Device images were provided.No further information.This is 1 of 2 reports for this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were added/corrected: d4, h6: clinical code, impact code.The revision reported may have been the result of infection/metallosis, loosening, center cage disassembly and fracture, and metal debris generation.The infection and loosening cannot be confirmed as serial radiography and pathology reports were not provided.The reported metallosis cannot be confirmed from the provided images and the devices were not returned for evaluation.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 information.The following sections were updated: h3, h6, h11.No device was returned for evaluation; radiograph images were provided; however, the reported event was unable to be confirmed.The review identified the reported metallosis cannot be confirmed from the provided images.A review of complaint history determined that no further action is required as no trends were identified.The revision reported may have been the result of infection/metallosis, loosening, center cage disassembly and fracture, and metal debris generation.The infection and loosening cannot be confirmed as serial radiography and pathology reports were not provided.The reported metallosis cannot be confirmed from the provided images and the devices were not returned for evaluation.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: 23576556
• Report Number: 1038671-2025-03357
• Device Sequence Number: 9532510
• 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: 2019
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 02/03/2026; 02/10/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 02/05/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male