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

Model Number EQUINOXE REVERSE 42MM HUMERAL LINER +0

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

Patient Problem Pain (1994)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: sup/post aug plate, r rs glenoid baseplate (cat#: 320-15-08 / serial#: (b)(4), glenosphere 42mm (cat#: 320-06-42 / serial#: (b)(4).As reported, the 78 y/o male patient presented with shoulder pain.The surgeon revised the glenoid to a competitor's device and replaced the liner with a new 42+2.5.There was no breakage of the device.There was no surgical delay/prolongation.The 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 to the sales rep for evaluation.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 shoulder pain and surgical revision cannot be conclusively determined; however, it is most likely due to patient related conditions.These devices are used for treatment not diagnosis.

Event Description

As reported, the 78 y/o male patient presented with shoulder pain.The surgeon revised the glenoid to a competitor's device and replaced the liner with a new 42+2.5.There was no breakage of the device.There was no surgical delay/prolongation.The 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 to the sales rep to return for evaluation.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL LINER +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: 15740999
• MDR Text Key: 303147943
• Report Number: 1038671-2022-01410
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• 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
• Report Date: 11/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 42MM HUMERAL LINER +0
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 98 KG