MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 62 y/o male patient underwent rtsa surgery.At a later date, the patient underwent a back surgery procedure.Following this procedure, the patient reported shoulder pain.The patient was observed to be dislocated.In revision surgery, the humeral liner component was observed to be dislodged from the tray.The liner was replaced.There was no breakage of a device or surgical delay/prolongation, images and x-rays received.The device is not available for evaluation due to explants are retained by the hospital.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of a combination of dislocation and humeral liner disassociation.It is unclear if the dislocation allowed for the humeral liner to disassociate or if the humeral liner disassociation-which may have been the result of either incomplete seating of the liner during implantation, bone impingement, patient conditions, or any combination of these possibilities-led to the dislocation as the explanted device was not returned for evaluation.The most probable root cause associated with the reported event of ¿humeral liner disassociation¿ is associated with post-operative disassociation of the humeral liner component from the humeral adapter tray/plate.Do not use for humeral liner seating difficulty.Furthermore, the most probable root cause with the event of ¿dislocation¿ is associated with the device not remaining in an expected location.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16545563
• Report Number: 1038671-2023-00442
• Device Sequence Number: 6325820
• Product Code: KWT
• UDI-Device Identifier: 10885862086716
• UDI-Public: 10885862086716
• 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: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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: 03/26/2023
• Device Model Number: EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0
• Device Catalogue Number: 320-42-10
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2018
• 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: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; EQ REV GLENOID PLATE; EQ REV LOCKING SCREW; EQ REVERSE TORQUE DEFINING SCREW KIT; EQUINOXE REVERSE SHOULDER DRILL KIT; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM; GLENOSPHERE 42MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male