MAUDE Adverse Event Report: EXACTECH, INC. EQ REVERSE TORQUE DEFINING SCREW KIT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-20-00
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.D10: (b)(6), 300-30-09 - equinoxe preserve stem 9mm, (b)(6), 320-02-42 - rs expanded glenosphere 42mm, +4mm offset, (b)(6), 320-10-05 - equinoxe reverse tray adapter plate tray +5, (b)(6), 320-15-01 - eq rev glenoid plate, (b)(6), 320-15-05 - eq rev locking screw, (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6), 320-42-03 - 145-deg pe 42mm hum liner +2.5, (b)(6), 531-20-00 - shldr gps rvrs drill kit, (b)(6), 531-78-20 - shouldr gps hex pins kit, (b)(6), a10012 - gps implant kit v2.
Event or Problem Description
As reported, approximately 1 year and 11 months post initial right total shoulder arthroplasty (tsa), the patient reached for something and felt their shoulder was "off".The patient presented to the clinic and x-rays showed the tray had dissociated from the stem resulting in a revision of the shoulder.The tray and liner together had dissociated from the stem, with the torque screw visible in the tray.The screw had not broken off in the stem and all threads could be visualized in the stem.After separating the liner from the tray, it appeared the torque screw failed and backed out of the stem completely, causing the tray and liner to dissociate from the stem and shift superior.The stem was still well fixed and the surgeon determined the threads were not damaged.The surgeon retained the stem and swapped out the glenosphere, tray and liner.The patient was revised to a 46 expanded sphere, new locking screw, updated 10mm tray, new torque screw, and a 46mm 2.5mm liner.No parts or pieces of the new implants fell into the patient.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, h6.Mdr section codes updated/corrected: a, b, c, d, g.The reason for the revision is likely due to the disassembly of the torque defining screw, and thus the humeral tray and liner assembly, from the humeral stem.Potential contributions may include patient conditions, incomplete seating or forces on the underside of the humeral tray at the time of implantation secondary to unintended contact with protruding bone, or an issue with insufficient application of torque or cross-threading of the screw during assembly.However, this cannot be confirmed because the components were not returned for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQ REVERSE TORQUE DEFINING SCREW KIT
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21219458
• Report Number: 1038671-2025-00371
• Device Sequence Number: 14284431
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320-20-00
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 10/17/2025
• Date Device Manufactured: 11/30/2022
• 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: Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male