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 Codes	Structural Problem (2506); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 72 y/o male patient's right shoulder was revised to a reverse shoulder.The glenosphere locking screw and glenosphere appeared to have backed away from the glenoid baseplate.The glenosphere locking screw was sitting proud and ended up wearing through the liner and made contact with the humeral tray.Surgeon replaced the 38 glenosphere, glenosphere locking screw, liner, reverse shoulder torque screw and humeral tray with new components.Patient was last known to be in stable condition following the event.Photos attached.Unable to obtain x-rays.Devices are not returning.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): glenosphere locking screw, liner, reverse shoulder torque screw, humeral tray.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d4, d6b - explant date is unknown.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/ additional information.The following sections were corrected/added: b1, b2, b5, d1, d8, g1, h6: clinical code, medical device problem code, component code, type of investigation, investigation findings and investigation conclusions.The revision reported was likely the result of the glenosphere locking screw backing out from the glenoid baseplate, which led to articulation between the screw and the humeral liner and humeral tray.This unintended contact likely led to wear of the liner and the tray.However, the sequence of events cannot be confirmed, and the cause of the screw loosening cannot be determined as the devices were not returned for evaluation and radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that this male patient's right shoulder was revised to a reverse shoulder.The glenosphere locking screw and glenosphere appeared to have backed away from the glenoid baseplate.The glenosphere locking screw was sitting proud and ended up wearing through the liner and made contact with the humeral tray.Surgeon replaced the 38 glenosphere, glenosphere locking screw, liner, reverse shoulder torque screw and humeral tray with new components.Patient was last known to be in stable condition following the event.Photos attached.Unable to obtain x-rays.Devices are not returning.

• 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, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18061026
• Report Number: 1038671-2023-02667
• Device Sequence Number: 6590973
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 01/23/2026

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 Catalogue Number: 320-15-05
• Device Lot Number: 149982004
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 01/22/2026; 01/22/2026
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 01/23/2026; 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 62 KG