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

Catalog Number	320-35-01
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: a10012 - gps implant kit v2 (b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6) 320-31-36 - glenosphere, 36mm (b)(6) 320-36-00 - 145-deg pe 36mm hum liner +0 (b)(6) 320-35-01 - small glenoid plate (b)(6) 300-01-09 - equinoxe, humeral stem primary, press fit 9mm (b)(6) 320-15-05 - eq rev locking screw (b)(6) 531-78-20 - shouldr gps hex pins kit (b)(6) 320-20-00 - eq reverse torque defining screw kit (b)(6) 531-20-00 - shldr gps rvrs drill kit (b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).
Event or Problem Description
It was reported that a female patient, initial left shoulder implanted in (b)(6) 2021, underwent a revision procedure in (b)(6) 2024, approximately 3 years 7 months post the initial procedure.Two reverse screws broke requiring the revision.The glenoid components, liner, and tray were replaced.None of the broke pieces fell into the patient wound site.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.The explanted devices are not available for return.They were sent to pathology.No device images were able to be obtained.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay updated/corrected information.The following section was updated: d4 - catalog #, serial #, exp date, udi.D10: concomittant device update.H4 - mfg date.The following sections were corrected: d4 - catalog #, serial #, exp date, udi.D10 - 320-35-01 / 6495839 no longer applies.

• 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; gainseville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21035048
• Report Number: 1038671-2024-05050
• Device Sequence Number: 14483296
• Product Code: KWT
• UDI-Device Identifier: 10885862534866
• UDI-Public: 10885862534866
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 01/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 320-35-01
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2020
• 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: 320-10-00 - 6864766
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female