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

Catalog Number	314-02-02
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Muscle/Tendon Damage (4532)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's shoulder was revised approximately 13 years 6 months post initial operation.The patient presented to the surgeons office with complaints of pain and decreased motion in their shoulder.It is shown on imaging that the glenoid implant is worn and potentially loose.The primary shoulder has migrated superiorly indicating rotator cuff failure.The humeral head, replicator plate and primary torque screw were removed.The all poly glenoid was loose and removed from the joint.There was bone and tissue growth around the glenoid that was debrided.There was osteolysis around the humeral stem and behind the glenoid.The humeral stem was check for version and stability.The humeral stem was stable and packed with bone graft.The glenoid was fractured across the central aspect.The surgeon believed a cage or peg implant would cause a larger fracture.Bone graft was applied to the glenoid.The surgeon used a djo reverse baseplate with a central screw and locking peripheral screws along with a 36mm glenosphere.The tray and liner were trailed up to a +2.5mm constrained for 36mm and were stable through rom.The surgeon implanted that construct with the real implants.Positioning was confirmed on x-ray and final rom was assessed.The patient left the or stable.
Additional Manufacturer Narrative
D10 concomitants: 300-01-11 - equinoxe, humeral stem primary, press fit 11mm (b)(6), 300-10-15 - equinoxe replicator plate 1.5mm o/s (b)(6), 300-20-02 - equinox square torque define screw drive kit (b)(6), 310-01-44 - equinoxe, humeral head short, 44mm (alpha) (b)(6).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.
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: b, c, d, g.The revision reported was likely the result of glenoid loosening and prosthesis wear as reported.The glenoid loosening and prosthesis wear was likely due to rotator cuff failure, causing the glenoid component to have abnormal articulation with the humeral head.However, this cannot be confirmed as the components were not returned for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE GLENOID, PEGGED ALPHA, SMALL
• 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: 21627553
• Report Number: 1038671-2025-01596
• Device Sequence Number: 20915590
• Product Code: HSD
• UDI-Device Identifier: 10885862084477
• UDI-Public: 10885862084477
• 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: 2011
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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 Expiration Date: 02/09/2014
• Device Catalogue Number: 314-02-02
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2009
• 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: 69 YR
• Patient Sex: Female