MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 01/01/2022

Event Type  Injury  

Event Description

As reported, surgeon revised the patient's shoulder due to dislocation.The poly was well-fixed to the tray.Patient was revised to competitor's device.There was no breakage of a device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales res was unable to obtain x-rays or photos.The device is not available for evaluation.

Manufacturer Narrative

Concomitant medical products: concomitant products: equinoxe, humeral stem primary, press fit 13mm (cat# 300-101-13 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, surgeon revised the patient's shoulder due to dislocation.The poly was well-fixed to the tray.The patient was revised to competitor's device.Patient is overweight.There was no breakage of a device.There was no surgical delay/prolongation.The patient was last known to be in stable condition following the event.The sales rep was unable to obtain x-rays or photos.The device is not available for evaluation.No additional information has been provided after multiple attempts.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 shoulder dislocation and subsequent revision cannot be conclusively determined; however, it is most likely patient related conditions as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• Type of Device: 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: 15739602
• MDR Text Key: 303143847
• Report Number: 1038671-2022-01409
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• Device Catalogue Number: 320-10-00
• Device Lot Number: 48520002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 84 KG