MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: serial number item number and full description, (b)(6).314-13-03 - equinoxe cage glenoid medium, alpha, (b)(6).300-10-15 - equinoxe replicator plate 1.5mm o/s, (b)(6).310-01-44 - equinoxe, humeral head short, 44mm (alpha).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a equinoxe shoulder study, that a 63 yo female patient, initial right shoulder implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2023, approximately 3 years 11 months post the initial procedure due to aseptic humeral loosening.Date of onset,(b)(6) 2023.The standard humeral stem, replicator plate, torque screw, humeral head, and glenoid were removed.The subscapularis was repaired, and a biceps tenodesis was performed.The study states the event was definitely related to the devices and the procedure.The outcome indicates continuing.No device returns anticipated due to clinical study guidelines.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d1/d2a/d2b, h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported may be the result of the humeral loosening as reported.However, the loosening cannot be confirmed and any potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as the devices 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.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17643681
• Report Number: 1038671-2023-02083
• Device Sequence Number: 5680000
• Product Code: HSD
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
• Device Catalogue Number: 300-01-13
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 05/20/2025
• Date Device Manufactured: 04/10/2019
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White