MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE SHOULDER SYSTEM; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO

Model Number	STEMLESS HUMERAL HEAD 47MM X 18MM X BETA
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032); Discomfort (2330)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately four months post initial right tsa, the 63 y/o male had a revision to remove existing stemless humeral implants and revise to stemmed humeral implant and anatomic glenoid component.The patient had the stemless humeral head and cage removed and an equinoxe humeral stem was implanted along with a laser cage glenoid.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photo/x-rays.The devices are not available for evaluation due to hospital retains the explanted products.
Additional Manufacturer Narrative
Section d10: concomitant products : stemless humeral cage size 3.(cat# 300-60-03 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: d1, d4, d10, g4, h6.D10: (b)(6) 300-60-03 - stemless humeral comp laser cage, size 3.(b)(6) 319-01-32 - steinmann pin sterile 3.2mm x 178mm.H11: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, cannot be conclusively determined.Additionally, the devices were not returned for evaluation, and images, radiographs, and patient information were not 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 SHOULDER SYSTEM
• Common Device Name: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO
• 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: matt collins
• MDR Report Key: 19185042
• Report Number: 1038671-2024-00985
• Device Sequence Number: 15278514
• Product Code: PKC
• UDI-Device Identifier: 10885862537119
• UDI-Public: 10885862537119
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 04/29/2026

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: STEMLESS HUMERAL HEAD 47MM X 18MM X BETA
• Device Catalogue Number: 310-61-47
• Device Lot Number: 402625003
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 04/17/2025; 04/08/2026
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 04/28/2025; 04/29/2026
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male