MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD TALL, 47MM (BETA); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	310-02-47
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Arthropathy (4894)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: serial #: (b)(4), category #: a10012 - gps implant kit v2.Serial #: (b)(4), category #: 300-20-02 - equinox square torque define screw drive kit.Serial #: (b)(4), category #: 314-13-33 - equinoxe cage glenoid m, post aug, right.Serial #: (b)(4), category #: 300-10-15 - equinoxe replicator plate 1.5mm o/s.Serial #: (b)(4), category #: 300-30-10 - equinoxe preserve stem 10mm.Serial #: (b)(4), category #: 531-78-20 - shouldr gps hex pins kit.
Event or Problem Description
As reported, post-op x-rays reflected ideal implant positioning on surgery date (b)(6) 2022.Anatomic shoulder replacement reduced pain but upon some subscap and supraspinatus tears, humerus was high riding.The surgeon decided to upsize the humeral stem, change the replicator size and use the shorter 47 humeral head, rather than converting to reverse.Patient was adamant about an anatomic replacement.This is what partially determined the revision to redo the atsa, rather than converting to rtsa.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the shoulder dislocation and subscap tears cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.

• Brand Name: EQUINOXE, HUMERAL HEAD TALL, 47MM (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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16321759
• Report Number: 1038671-2023-00117
• Device Sequence Number: 8645470
• Product Code: HSD
• UDI-Device Identifier: 10885862083944
• UDI-Public: 10885862083944
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 310-02-47
• Device Catalogue Number: 310-02-47
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/24/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 06/18/2023; 06/11/2026
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 06/01/2023; 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male