MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	310-01-50
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3 years post op the initial right tsa, this female patient was revised due to significant metalosis with humeral head scratching against central cage of glenoid.The peripheral pegs were still connected to poly but was migrated away from original position.The central cage remained in its original position well fixed.Glenoid was bone grafted and converted to arthrex baseplate and glenosphere.The humeral head and replicator were removed.A +0 tray and 36 +0 liner was implanted with good stability and rom.Patient last known to be in stable condition.Explants not available.
Additional Manufacturer Narrative
Concomitants: 300-01-11 - equinoxe, humeral stem primary, press fit 11mm sn: (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s sn: (b)(6), 300-20-02 - equinox square torque define screw drive kit sn: (b)(6), 310-01-50 - equinoxe, humeral head short, 50mm (beta) sn: (b)(6).The revision reported was likely the result of disassembly of the center cage from the glenoid body, leading to glenoid loosening, migration, and subsequent prosthesis wear between the retained center cage and the humeral head.There did not appear to be articular surface wear of the polyethylene in the provided image.Noncemented usage of the peripheral pegs likely contributed to the loosening and subsequent migration of the glenoid body.However, the contributions of initial implant alignment, lack of cement on the peripheral pegs, and wear to the series of events any cannot be confirmed as the devices were not returned for evaluation and no initial post-operative radiographs were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA)
• 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 INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22506050
• Report Number: 1038671-2025-02499
• Device Sequence Number: 8745469
• Product Code: HSD
• UDI-Device Identifier: 10885862083890
• UDI-Public: 10885862083890
• Combination Product (Y/N): N
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 07/15/2025

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: 310-01-50
• 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: 08/03/2022
• Initial Report FDA Received Date: 07/15/2025
• Date Device Manufactured: 02/06/2019
• 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: Hospitalization; Required Intervention
• Patient Sex: Female