MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-33
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374); Osteolysis (2377)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, initial right shoulder implanted on an unknown date, underwent a revision procedure in (b)(6) 2025.The patient had dislocated and was x-rayed which showed a broken glenoid.They were booked to revise.The surgeon removed the broken implant.The cage was snapped and had migrated as per the x ray.The wound was infected around the breakage.All parts and pieces were removed, and no fragments had fallen into the wound site.The cage had snapped off and was not attached to the baseplate.There were significant signs of wear to the poly.A spacer was implanted, and a new ct was ordered.It looks like the patient will need a custom and hrp due to bone loss.The patient required prolonged hospitalization as a direct result of this issue.They are waiting for the infection to clear and cts to be done to formulate a plan of next steps.There were no surgical delays during the procedure.Device images and x-rays were provided.The explanted devices are available for return.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: d9 - device return date.H3 - the revision was likely due to a combination of infection, loosening, fracture of the center peg leading to migration of the polyethylene glenoid body.Migration of the polyethylene likely allowed for subsequent metal-on-metal wear between the retained center cage and humeral head and abnormal wear/damage to the polyethylene.Contributing factors to the reported failure may include anatomic instability within the shoulder joint, misalignment or incomplete seating of the peripheral pegs/center cage of the glenoid at the time of implantation, and potentially a lack of cement on the peripheral pegs.However, the sequence of events and/or relationship between the reported dislocation, infection, and loosening cannot be determined and infection cannot be confirmed from the provided information.H6 - clinical, problem, component, investigation type, findings, conclusion codes added the following sections were corrected: h6 - component code 4756, inv codes 4118, 3233, 11, no longer applies.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE
• 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
• MDR Report Key: 21366762
• Report Number: 1038671-2025-00868
• Device Sequence Number: 18255678
• Product Code: KWS
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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 Expiration Date: 08/06/2023
• Device Catalogue Number: 314-13-33
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2018
• 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