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

Catalog Number	320-15-05
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6), 320-15-03 - rs glenoid plate post aug, 8 deg, left.(b)(6), 320-20-00 - eq reverse torque defining screw kit.(b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 320-42-00 - equinoxe reverse 42mm humeral liner +0.(b)(6), a10012 - gps implant kit v2.
Event or Problem Description
It was reported that a 79 yo male patient, initial left shoulder implanted in (b)(6) 2018, underwent a revision procedure in (b)(6) 2024, approximately 7 years post the initial procedure.The patient presented to the surgeon with complaints about some mile pain in their shoulder.During the procedure, when opened, they presented with loosening on the glenoid side and a snapped screw.It was indicated a fall was suspected.All devices were removed.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.No explanted devices were available for return as they were sent to ¿rph for study¿.Device images were provided.No further information.
Additional Manufacturer Narrative
This report is a correction of a previously submitted erroneous 5-day report.This event is a 30-day reportable event only and does not represent an event that necessitates remedial action to prevent an unreasonable risk of substantial harm to public health.Corrected fields: g6 (should have been 30-day initial medwatch).
Additional Manufacturer Narrative
Correction - device information reported in the initial report is no longer valid for the following fields d4 - the device catalog #, exp date, serial #, udi h4 - mfg date additional information h3 - the revision reported was likely the result of glenoid loosening and fracture of one of the compression screws.Although the sequence of events cannot be confirmed, the loosening of the baseplate may have allowed for excess stress to be applied to a well-fixed compression screw, subsequently resulting in device fracture.A contributing factor to the event may have been a patient fall.However, this cannot be confirmed because the component was not returned for evaluation and radiographs were not provided.

• Brand Name: EQUINOXE
• Common Device Name: PROSTHESIS, SHOULDER, NON-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: 19963207
• Report Number: 1038671-2024-02786
• Device Sequence Number: 7079966
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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,Followup,Followup
• Report Date (Section B): 11/05/2024

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: 04/18/2023
• Device Catalogue Number: 320-15-05
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 09/27/2024; 10/31/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/27/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• 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 Age: 79 YR
• Patient Sex: Male