MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-07
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 320-01-38 - equi rev 38mm glenosphere: (b)(6), 320-10-00 - equi rev tray adapter plate tray +0: (b)(6), 320-15-01 - eq rev glenoid plate: (b)(6), 320-15-05 - eq rev locking screw: (b)(6), 320-20-00 - eq reve torque defining screw kit: (b)(6), 320-20-22 - eq rev comp scr lck cap kit, 4.5 x 22mm: (b)(6), 320-20-22 - eq rev comp scr lck cap kit, 4.5 x 22mm: (b)(6), 320-20-30 - eq rev comp scr lck cap kit, 4.5 x 30mm: (b)(6), 320-20-30 - eq rev comp scr lck cap kit, 4.5 x 30mm: (b)(6), 320-38-13 - equi rev 38mm humeral const liner +2.5: (b)(6).The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was 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
It was reported that the patient underwent an initial tsa (total shoulder arthroplasty) on the left side.Subsequently, the patient experienced a humeral periprosthetic fracture and an infection.As a result, the surgeon removed all implants and replaced with a cement spacer as part of the first-stage revision.They have a second-stage revision planned in the future.Patient was last known to be in stable condition following the event.No further information available.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23458353
• Report Number: 1038671-2025-03260
• Device Sequence Number: 7968671
• Product Code: KWS
• UDI-Device Identifier: 10885862079299
• UDI-Public: 10885862079299
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2025

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: 300-01-07
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/03/2025
• Date Device Manufactured: 06/21/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Female