MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-42-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6) 320-01-42 - equinoxe reverse 42mm glenosphere, (b)(6) 320-15-05 - eq rev locking screw, (b)(6) 300-30-08 - equinoxe preserve stem 8mm, (b)(6) 315-35-00 - glnd kwire, (b)(6) 320-15-01 - eq rev glenoid plate, (b)(6) 320-20-00 - eq reverse torque defining screw kit, (b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6) 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6) 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm.
Event or Problem Description
As reported, implants are being revised due to humeral liner dissociation.The initial implant date is (b)(6) 2020.The glenosphere, liner, adapter tray, screw kit and locking screw were revised.The reported event is not related to the breakage of a device.The event did not lead to a surgical delay/prolongation.Patient, 76 year old male, was last known to be in stable condition following the event.No additional patient/medical information provided.Unable to obtain images or x-rays.Product not returning: disposed by hospital.
Additional Manufacturer Narrative
Additional information: h3 - the revision reported may have been the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, an unreported post traumatic event, or any combination of these possibilities, which led to humeral liner disassociation/disassembly.However, this cannot be confirmed as the device was not returned for evaluation, and images, radiographs, and product information were not provided.H6 - inv codes.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19609677
• Report Number: 1038671-2024-02112
• Device Sequence Number: 8084395
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 10/10/2024

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: 06/18/2024
• Device Catalogue Number: 320-42-03
• 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: 06/23/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2019
• 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: 76 YR
• Patient Sex: Male