MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-09
Medical Device Problem Codes	Osseointegration Problem (3003); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Aseptic loosening (4883)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-01-09 - equi, hum stem primary, press fit 9mm: (b)(6), 320-10-00 - equi rev tray adapter plate tray +0: (b)(6), 320-15-05 - eq rev locking screw: (b)(6), 320-20-00 - eq rev torque defining screw kit: (b)(6), 320-20-26 - eq rev comp scr lck cap kit, 4.5 x 26mm: (b)(6), 320-20-30 - eq rev comp scr lck cap kit, 4.5 x 30mm: (b)(6), 320-20-34 - eq rev comp scr lck cap kit, 4.5 x 34mm: (b)(6), 320-20-34 - eq rev comp scr lck cap kit, 4.5 x 34mm: (b)(6), 320-31-36 - glenosphere, 36mm for small reverse: (b)(6), 320-35-01 - small glenoid plate: (b)(6), 320-36-13 - 36mm humeral liner +2.5mm constrained: (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.Approximately 13 years post initial operation, the patient's humeral stem subsided and became loose following a fracture.The surgeon replaced the stem, glenosphere, humeral tray and liner.An uncemented stem was implanted.Patient was last known to be in stable condition following the event.No further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6: medical device problem code the revision reported may have been the result of a pre-existing bone fracture which likely resulted in inadequate initial fixation of the humeral stem and subsequent loosening and subsidence.However, this cannot be confirmed because the components were not returned for evaluation, and no images or radiographs were provided.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 and corrected information.The following sections were updated: d4, g4, h4.The following sections were corrected: d1, d2a, d11, h6.D11: 320-10-00 - equi rev tray adapter plate tray +0: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq rev torque defining screw kit: (b)(6).320-20-26 - eq rev comp scr lck cap kit, 4.5 x 26mm: (b)(6).320-20-30 - eq rev comp scr lck cap kit, 4.5 x 30mm: (b)(6).320-20-34 - eq rev comp scr lck cap kit, 4.5 x 34mm: (b)(6).320-20-34 - eq rev comp scr lck cap kit, 4.5 x 34mm: (b)(6).320-31-36 - glenosphere, 36mm for small reverse: (b)(6).320-35-01 - small glenoid plate: (b)(6).320-36-13 - 36mm humeral liner +2.5mm constrained: (b)(6).

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 23570331
• Report Number: 1038671-2025-03337
• Device Sequence Number: 10120245
• Product Code: HSD
• 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: 2012
• 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,Followup,Followup
• Report Date (Section B): 02/03/2026

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: 10/30/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 01/12/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 02/02/2026; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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
• Patient Sex: Female