MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-11
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Bone Notching (4890)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient presented to surgeon with a painful shoulder and decreased function following a right shoulder replacement.The pre-op imaging and assessment showed what appears to be a loose humeral component and inferior scapular notching on the glenoid, with some bone changes/resorption on both the humerus and glenoid.It was suspected that the glenoid component may be loose as well.The patient was scheduled for a revision reverse total shoulder arthroplasty with humeral exchange and possible glenoid / complete revision.During the procedure, it was confirmed that the humeral stem and component were loose and not well fixed in the bone.The surgeon was able to pull the construct out by hand not needing extraction tools.There was no bone growth onto the humeral stem.The glenoid baseplate was assessed and showed/presented to be well fixed after testing it with a slap hammer and leverage bar.The surgeon debrided and irrigated the shoulder joint and kept the well-fixed baseplate in.A 38mm +4 lateralized glenosphere was replaced to help push the humerus away from the inferior glenoid bone, along with a new humeral stem that was cemented into the humeral canal and a new tray and liner construct.The joint felt stable, confirmed on x-ray, the placement and the existing plate and screws construct from the fracture fix were able to stay and did not need to be removed or revised.The patient was last known to be in stable condition following the event.No further information is available.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25485848
• Report Number: 1038671-2026-00771
• Device Sequence Number: 10395185
• Product Code: KWS
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2023
• Device Catalogue Number: 300-01-11
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/12/2026
• Date Device Manufactured: 10/22/2013
• 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: 66 YR
• Patient Sex: Female