MAUDE Adverse Event Report: EXACTECH, INC. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-20-30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 320-31-36 - glenosphere, 36mm: (b)(6), 300-01-14 - eq huml stem primary press fit 14mm: (b)(6), 320-10-00 - eq rev tray adapter plate tray +0: (b)(6), 320-36-00 - 145-deg pe 36mm hum liner +0:(b)(6), 320-15-05 - eq rev locking screw: (b)(6), 320-20-00 - eq reverse torque defining screw kit: (b)(6), 320-20-18 - eq rev comp screw lck cap kit, 4.5 x 18mm: (b)(6), 320-20-22 - eq rev comp screw lck cap kit, 4.5 x 22mm: (b)(6), 320-20-26 - eq rev comp screw lck cap kit, 4.5 x 26mm: (b)(6), 321-20-00 - equinoxe reverse shoulder drill kit: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a 71 yo female patient, who had a left rtsa, underwent a revision procedure approximately 4 years 2 months post the initial procedure.The patient complained of pain.The baseplate was observed to be dislodged from the glenoid on ct.One of the screws was observed to be broken.The humeral liner & tray were removed.The stem was still well-fixed despite proximal humeral bone loss.The glenosphere was removed.The baseplate with all four screws was pulled out as one piece.One of the screws was broken.The surgeon filled the bone void with cap & used competitor¿s components for the glenoid baseplate & glenosphere.The surgeon then implanted a new humeral tray & liner.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.An x-ray image was provided.The explanted devices are not available for return.Images were provided.No further information.This is 1 of 2 reports for this event.

• Brand Name: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM
• 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: 24048723
• Report Number: 1038671-2026-00038
• Device Sequence Number: 13127893
• Product Code: KWT
• UDI-Device Identifier: 10885862086556
• UDI-Public: 10885862086556
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 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
• Report Date (Section B): 01/12/2026

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: 11/18/2025
• Device Catalogue Number: 320-20-30
• 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: 12/27/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female