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

Model Number	EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 78 y/o male patient had a revision due to rtsa was unstable and anteriorly dislocated within 1 week post op.Patient was revised tray/liner/torque screw to hat, a new liner, new torque screw.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays received.The devices are not available for evaluation due to hospital would not decontaminate.No additional patient/medical information provided.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of anterior total shoulder dislocation approximately one week post-op, which led to the damage on the explanted humeral liner.The reported dislocation could be confirmed from the provided radiographs.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL CONST 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 ; 3525541928
• MDR Report Key: 19010607
• Report Number: 1038671-2024-00691
• Device Sequence Number: 11732619
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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 Model Number: EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5
• Device Catalogue Number: 320-42-13
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; REVERSE TORQUE SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 86 KG