MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-13
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (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) 300-30-08 - equinoxe preserve stem 8mm.(b)(6) 310-01-44 - equinoxe, humeral head short, 44mm (alpha).(b)(6) 319-01-32 - steinmann pin sterile 3.2mm x 178mm.(b)(6) 321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a male patient, initial right atsa implanted in (b)(6) 2022, underwent a revision procedure in (b)(6) 2025, approximately 2 years 4 months post the initial procedure.The surgeon revised an anatomic total shoulder because of a failed rotator cuff to a reverse.The surgeon kept the humeral stem.There were no surgical delays or device breakages during the procedure.No x-rays were able to be obtained.The explanted devices are not available for return.They were not able to be obtained by the sales rep.Device images were provided.The patient had a successful rsa surgery.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: b, c, d.The revision reported was likely due to rotator cuff failure as reported.The cause of the wear and fracture of the glenoid component may be due to incomplete seating of the implant and/or off-axis drilling of the peg holes during implantation leading to a rocking horse effect.However, the series of events could not be confirmed as the devices were not returned for evaluation and no radiographs were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE SHOULDER COMPONENTS
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21569176
• Report Number: 1038671-2025-01532
• Device Sequence Number: 8647024
• Product Code: KWS
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• 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): 09/08/2025

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: 12/01/2024
• Device Catalogue Number: 314-13-13
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male