MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 11MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	300-30-11
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	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 300-30-11 - equinoxe preserve stem 11mm: b016760; 322-38-03 - 145-deg pe 38mm hum liner +2.5: a850864; 322-10-00 - humeral adapter tray, +0: b328360; 320-06-38 - glenosphere 38mm: b249706; 320-15-06 - rs glenoid plate ext cag +10mm cage peg: b360818.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial total shoulder replacement on the right side.During initial implantation, the patient experienced a humeral fracture; intra-operative crack in proximal humerus at base of tuberosity.As a result, the patient underwent a cerclage fixation.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
The reason for the intraoperative bone fracture reported cannot be conclusively determined but may be related to a patient condition.However, this cannot be confirmed based on the information provided.D1: corrected.D4: corrected.G4: corrected.H4: corrected.H6: corrected health effect and investigation clinical codes.

• Brand Name: EQUINOXE PRESERVE STEM 11MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21636052
• Report Number: 1038671-2025-01609
• Device Sequence Number: 9402262
• Product Code: PHX
• UDI-Device Identifier: 10885862515797
• UDI-Public: 10885862515797
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 300-30-11
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 08/13/2025
• Date Device Manufactured: 04/23/2024
• 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: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White