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

Catalog Number	310-02-50
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 69 yo male patient, initial right shoulder implanted in (b)(6) 2017, underwent a conversion of an anatomic shoulder to a reverse approximately 7 years 8 months post.The surgeon suspected the glenoid implant had disassociated.Upon finding the central peg had disassociated.The surgeon revised glenoid to a competitor's device.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available for return as they were discarded at the hospital.Device image was provided.No further information.This is 1 of 2 reports for this event.See mdr #1038671-2025-00805.
Additional Manufacturer Narrative
D10: concomitants: 300-01-13 humeral stem, 13mm (b)(6), 300-10-15 anatomic replicator plate, 1.5mm o/s (b)(6), 300-20-02 square torque defining screw kit (b)(6), 310-02-50 humeral head t 50mm humeral head t 50mm (b)(6).H3 - the revision reported is most likely the result of the fracture of the center peg and cage from the glenoid body and subsequent glenoid loosening as reported and subsequent unintended metal-on-metal wear.Potential contributions of patient or user-related issues to the event cannot be determined from the reported information.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported is most likely the result of the fracture of the center peg and cage from the glenoid body and subsequent glenoid loosening as reported and subsequent unintended metal-on-metal wear.Potential contributions of patient or user-related issues to the event cannot be determined from the reported information.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 TALL, 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21954760
• Report Number: 1038671-2025-01961
• Device Sequence Number: 8382073
• Product Code: HSD
• UDI-Device Identifier: 10885862083951
• UDI-Public: 10885862083951
• 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: 2017
• 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): 05/07/2025

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: 03/30/2025
• Device Catalogue Number: 310-02-50
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male