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	Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s, (b)(6), 300-20-02 - equinox square torque define screw drive kit, (b)(6), 300-30-10 - equinoxe preserve stem 10mm, (b)(6), 315-35-00 - glnd kwire, (b)(6), 315-35-00 - glnd kwire.H3: customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that this patient's right shoulder was revised approximately 7 years post initial operation.The poly had been worn and broken into pieces.There was a main fracture across the middle of poly.The peripheral pegs and poly were removed with forceps.The middle of the center cage was still in the bone and solidly fixed.The removal tool was used to extract in a single piece.The patient's rotator cuff was fully intact.The preserve stem was exposed proximally due to lytic lesions, but was noted to be well fixed.Osteolysis was also observed on the glenoid side which required bone grafting.Patient was revised from an anatomic to reverse.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h11.Upon reassessment of the reported event, it was determined that this device did not cause or contribute to the reported event.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.
Event or Problem Description
It was reported that this patient's right shoulder was revised approximately 7 years post initial operation.The poly had been worn and broken into pieces.There was a main fracture across the middle of poly.The peripheral pegs and poly were removed with forceps.The middle of the center cage was still in the bone and solidly fixed.The removal tool was used to extract in a single piece.The patient's rotator cuff was fully intact.The preserve stem was exposed proximally due to lytic lesions but was noted to be well fixed.Osteolysis was also observed on the glenoid side which required bone grafting.Patient was revised from an anatomic to reverse.Patient was last known to be in stable condition following the event.Additional information was received that confirmed there was metalosis from the anatomic head articulating on the pegs.The representative also noted, the pegs had to be reamed out to remove them (the internal threads on the removal device didn¿t grip).As a result, they had metalosis and bone loss.The glenoid was then bone grafted for the reverse baseplate.

• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22563799
• Report Number: 1038671-2025-02538
• Device Sequence Number: 9247586
• Product Code: HSD
• UDI-Device Identifier: 10885862083890
• UDI-Public: 10885862083890
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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 Expiration Date: 06/21/2026
• 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: 06/28/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 01/16/2026
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 12/04/2025; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male