MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	CTA HUMERAL HEAD SHORT, 47MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 64 yo female patient, initial left shoulder implanted on (b)(6) 2022, underwent a revision procedure on (b)(6) 2023, approximately 5 months post the initial procedure.The hemi shoulder was converted to a reverse shoulder at the patient¿s request.The patient complained of no range of movement and pain on the left shoulder.The surgeon did a reverse on her other side, and she wanted her hemi converted to reverse to feel the benefits of the range of motion that she experiences with her other side.Patient was last known to be in stable condition following the event.The product is not returning as it was discarded by hospital.No further information.
Additional Manufacturer Narrative
Concomitants: 7278662 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.7122028 300-10-45 - equinoxe replicator plate 4.5mm o/s.7273947 300-20-02 - equinox square torque define screw drive kit.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6 based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to patient conditions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d4(remove all from initial report-suspect device unknown), g4 (remove 501k from initial report-unknown), h4(remove erroneous date from initial report) h6: clinical codes, medical device problem code, component code, types of investigation, investigation findings and investigation conclusion.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE
• 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 ; 2320 nw 66th ct; gainesville, FL ; 3523771140
• MDR Report Key: 16312335
• Report Number: 1038671-2023-00114
• Device Sequence Number: 6185524
• Product Code: HSD
• UDI-Device Identifier: 10885862171511
• UDI-Public: 10885862171511
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110706
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2025

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 Model Number: CTA HUMERAL HEAD SHORT, 47MM
• Device Catalogue Number: 310-21-47
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 02/07/2023; 11/20/2025
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/01/2023; 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female