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 Codes	Structural Problem (2506); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 years and 2 months post the initial right reverse total shoulder arthroplasty, the patient presented to the surgeon's office with complaints of pain and decreased range of movement.Upon examination and imaging review from previous post-op, and the recent office visit x-rays, and according to the implant record with a standard baseplate being used, it appeared the glenosphere was not completely engaged and down on the baseplate.However, the locking screw was still engaged and gave the surgeon a false feedback in the initial surgery that the implant was down and secure.The implant was not down completely and secure, and over time the glenosphere locking screw disengaged from the mechanism and the glenosphere implant leveraged off of the glenoid baseplate.There was/is evidence of humeral poly liner wear and bone resorption/osteolysis around the implants.The patient was revised, and during the revision, the patient's shoulder joint and surrounding tissue showed metallosis.The joint and tissues were debrided.The broken and disengaged implants were removed.The humeral stem was tested for stability.The glenoid baseplate showed to be stable, so the surgeon re-implanted a reverse glenosphere, locking screw, humeral tray, and liner.The patient's shoulder joint was irrigated well and closed.All fragments, parts and pieces were removed.There was a 5-15 minute delay as the surgeon had to spend extra time cleaning out/debriding the joint and surrounding tissue.The surgeon took extra time to make sure that the glenosphere was engaged onto the baseplate before inserting a new glenosphere screw.The patient left the operating room stable.The patient required prolonged hospitalization as a direct result of this issue.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: katy priest ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25336748
• Report Number: 1038671-2026-00673
• Device Sequence Number: 9806242
• 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: 2018
• 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
• Report Date (Section B): 05/29/2026

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: 04/04/2023
• Device Catalogue Number: 320-20-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female