MAUDE Adverse Event Report: EXACTECH, INC. EQ REV LOCKING SCREW; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-05
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's shoulder was reivsed approximately 1 year 6 months post initial operation.It was suspected that the glenosphere screw had backed out.However, surgeon had found that the glenosphere screw had broken into the glenoid baseplate.The screw had subsequently backed out and wearing the humeral poly causing lysis.After removal, surgeon re inserted a long peg baseplate and new implants as the stem was well fixed.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
D10 - concomitants: a515639 300-01-13 - equinoxe, humeral stem primary, press fit 13mm a373979 315-35-00 - glnd kwire a123870 320-01-38 - equinoxe reverse 38mm glenosphere a495898 320-10-00 - equinoxe reverse tray adapter plate tray +0 a269877 320-15-01 - eq rev glenoid plate a500944 320-20-00 - eq reverse torque defining screw kit a157145 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm s423951 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm s416818 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm 6892476 321-20-00 - equinoxe reverse shoulder drill kit h3: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision was likely due to fracture of the glenosphere locking screw leading to unintended contact with the liner and subsequent polyethylene wear.The reason for the fracture could not be determined from the information provided, but may be related to incomplete seating of the locking screw and/or partially disassembly of the device.However, this cannot be confirmed from the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQ REV LOCKING SCREW
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21263630
• Report Number: 1038671-2025-00521
• Device Sequence Number: 17294178
• 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: 2023
• 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): 05/02/2025

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: 320-15-05
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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: 65 YR
• Patient Sex: Male