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

Catalog Number	300-01-09
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.(b)(6), 315-35-00 - glnd kwire.(b)(6), 320-01-42 - equinoxe reverse 42mm glenosphere.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(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), 320-20-26 - 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), 320-42-13 - equinoxe reverse 42mm humeral const liner +2.5.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-01592.The revision reported was likely the result of infection and humeral loosening as reported.It remains unclear whether the reported infection played a contributing factor to the humeral loosening.However, infection and humeral loosening cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation 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.
Event or Problem Description
Report 2 of 2 for this event.As reported, approximately six (6) months status post a revision of a total shoulder arthroplasty due to infection, this patient was revised again due to infection.As the result, surgeon removed all implants from the patient.It was noted intraoperatively; the humeral sided implants were loose (cemented in).Purulence was observed on the glenoid side.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.No additional information is available.

• Brand Name: EQUINOXE, HUMERAL STEM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653
• MDR Report Key: 24660422
• Report Number: 1038671-2026-00309
• Device Sequence Number: 15775384
• Product Code: KWS
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• 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: 2022
• 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
• Report Date (Section B): 03/23/2026

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: 300-01-09
• 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: 11/21/2022
• Initial Report FDA Received Date: 03/23/2026
• Date Device Manufactured: 03/09/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Male