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	Structural Problem (2506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent an initial reverse total shoulder arthroplasty.Subsequently, it was observed in an x-ray that there was loosening of the glenosphere locking screw.The patient was revised and a new 36mm glenosphere, glenosphere locking screw, and humeral liner size 36/0 were implanted.There was no reported breakage of a device or surgical delay/prolongation.Patient outcome not provided.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25668201
• Report Number: 1038671-2026-00816
• Device Sequence Number: 12203602
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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
• 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: 06/17/2026
• Initial Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 01/13/2026
• 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; Required Intervention
• Patient Sex: Unknown