MAUDE Adverse Event Report: EXACTECH, INC. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-20-22
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6(a): unknown date approximately 10 years ago.D10: 320-38-00 - equinoxe reverse 38mm humeral liner +0: (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6), 320-15-01 - eq rev glenoid plate: (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, 320-01-38 - equinoxe reverse 38mm glenosphere: sn# (b)(6), 320-15-05 - eq rev locking screw: sn# (b)(6), 320-20-00 - eq reverse torque defining screw kit: sn# (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: sn# (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: sn# (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: sn# (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: sn# (b)(6), 321-20-00 - equinoxe reverse shoulder drill kit: sn# (b)(6), 315-35-00 - glnd kwire: sn# (b)(6), 315-35-00 - glnd kwire: sn# (b)(6).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.
Event or Problem Description
It was reported that the patient underwent an initial reverse total shoulder replacement on the left side.Subsequently, the patient experienced pain.Imaging revealed a broken screw in the glenoid and what appeared to be loosening around the implant, both glenoid and humerus.As a result, approximately ten years post-surgery, the patient underwent a revision.The stem was well fixed, stable and remains implanted.Metallosis was reported within the joint.Intraoperative cultures were negative for infection.The patient reported to anesthesia that at some point in the past, they had a fall.It is unknown when the fall occurred.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available at this time.

• Brand Name: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM
• 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
• MDR Report Key: 22898788
• Report Number: 1038671-2025-02840
• Device Sequence Number: 11619583
• Product Code: KWT
• UDI-Device Identifier: 10885862086532
• UDI-Public: 10885862086532
• 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 Explanted Year: 2025
• 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): 08/26/2025

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: 320-20-22
• 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: 08/10/2025
• Initial Report FDA Received Date: 08/26/2025
• 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 Age: 72 YR
• Patient Sex: Female