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

Catalog Number	314-02-03
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Implant Pain (4561); Insufficient Information (4580)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: 7236081 300-10-45 - equinoxe replicator plate 4.5mm o/s, a090374 300-20-02 - equinox square torque define screw drive kit, a137783 300-30-07 - equinoxe preserve stem 7mm, 7014366 310-01-44 - equinoxe, humeral head short, 44mm (alpha).H3: 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 definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 this patient's right shoulder was revised 2 year 2 months post initial operation.The central peg broke from implant and implant was displaced in shoulder.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, e, g.The revision reported may be the result of the glenoid fracture leading to migration as reported.The reported loss of range of motion was likely due to the reported displaced implant as the humeral head articulates on the glenoid implant component.The glenoid was reported to be fractured but radiographs and images were not available.Contributing factors to the reported fracture may include a combination of articular surface wear and thinning of the glenoid body, incomplete seating, and/or eccentric loading around a well-fixed center cage with loosening of the peripheral pegs may have led to the fracture but this cannot be confirmed from the information provided.Potential contributions of patient and user-related issues to the event cannot be determined from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE GLENOID, PEGGED ALPHA, MEDIUM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21859165
• Report Number: 1038671-2025-01850
• Device Sequence Number: 4695835
• Product Code: HSD
• UDI-Device Identifier: 10885862084484
• UDI-Public: 10885862084484
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 07/02/2025

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 Expiration Date: 08/18/2025
• Device Catalogue Number: 314-02-03
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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: Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female