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); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Septic loosening (4884)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a previous stemmed anatomic shoulder replacement, the poly glenoid had become loose, and had come away from the glenoid.After removing the implant, the surgeon noticed that the inferior posterior peg had broken and was not attached to the implant.It was still cemented into the glenoid, so the surgeon used a burr to remove the remaining peg.The surgeon removed all implants and inserted a cement spacer preparing for the 2nd stage revision which the patient will come back for.Due to the stem being extremely secure, the patients gt (greater tuberosity) broke whilst removing the stem.The surgeon explained to the patient they will probably require a hrp as part of the 2nd stage revision.There were device breakages and there were fragments, parts, pieced in the wound site which were removed by the surgeon and a wash out occurred.There were no surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were available.The explanted device is available for return.Device images were provided.Prosthesis wear was observed in the images.No further information.
Additional Manufacturer Narrative
D10: 300-10-45 - equinoxe replicator plate 4.5mm o/s, 310-01-44 - equinoxe, humeral head short, 44mm (alpha), 300-20-02 - equinox square torque define screw drive kit, 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.Should additional relevant information be obtained, a follow-up mdr will be submitted 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 23286871
• Report Number: 1038671-2025-03098
• Device Sequence Number: 5559450
• Product Code: HSD
• UDI-Device Identifier: 10885862657770
• UDI-Public: 10885862657770
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2021
• Device Catalogue Number: 314-02-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2016
• 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 Sex: Unknown