MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE 38MM GLENOSPHERE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products glenosphere locking screw (cat# 320-15-05 / serial# (b)(6).Humeral liner, 38mm, +0 (cat# 320-38-00 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately seven years post initial left tsa, the 70 y/o male patient was revised due to heterotopic ossification.Patient's glenosphere and liner were revised to exactech devices.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or photos.The devices are not available for evaluation as they were disposed at hospital.
Additional Manufacturer Narrative
Additional information: h3 - according to the information provided, approximately seven years following the initial left tsa, the patient was revised due to heterotopic ossification.The patient's glenosphere and liner were revised.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the heterotropic ossification and subsequent revision is likely due to patient conditions.H6 - health effect clinical code, component code, investigation codes.Corrected information: h6 - health effect clinical code.

• Brand Name: EQUINOXE REVERSE 38MM GLENOSPHERE
• 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: 18530988
• Report Number: 1038671-2024-00104
• Device Sequence Number: 6779291
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: EQUINOXE REVERSE 38MM GLENOSPHERE
• Device Catalogue Number: 320-01-38
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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: GLENOID PLATE; HUMERAL ADAPTER TRAY +0; HUMERAL STEM 13MM; TORQUE DEFINING SCREW KIT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male