MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 9MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-30-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-30-09 - equinoxe preserve stem 9mm: b016830, 322-36-00 - 145-deg pe 36mm hum liner +0: b165096, 322-10-00 - humeral adapter tray, +0: b119164m 320-31-36 - glenosphere, 36mm: b145649, 320-35-08 - small superior/posterior augglenoid plate,right: b148698.
Event or Problem Description
Intra-operatively of a right rtsa, it was reported via clinical study that the patient experienced a humeral fracture.It was further reported that a small medial calcar crack occurred during trialing.The action taken during the procedure was cemented stem and the outcome of this event remains continuing.The clinical report indicates that this event is unlikely related to the device(s) and possibly related to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, g4, h4, h6 mdr section codes updated/corrected: b, c, d, e, f the reason for the intraoperative bone fracture reported in cannot be conclusively determined but may be related to a patient condition.However, this cannot be confirmed based on the information 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 PRESERVE STEM 9MM
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20550404
• Report Number: 1038671-2024-04150
• Device Sequence Number: 3250699
• Product Code: KWT
• UDI-Device Identifier: 10885862515773
• UDI-Public: 10885862515773
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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 Catalogue Number: 300-30-09
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 09/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White