MAUDE Adverse Event Report: EXACTECH, INC. SHOULDER - IMPLANT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number SHOULDER IMPLANT

Device Problem Component Misassembled (4004)

Patient Problem Failure of Implant (1924)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Section d6b: explanted, give date - exact date not available.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, the female patient had a revision of the right shoulder for unknown reason.The tray, liner and torque screw were intact.The torque screw was in the tray but not attached to the humeral stem.Patient was revised to exactech devices, the tray, liner and torque screw were revised.There was no breakage of 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 due to hospital has a no return policy.

• Brand Name: SHOULDER - IMPLANT
• 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: 17258921
• MDR Text Key: 318451293
• Report Number: 1038671-2023-01544
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/05/2023

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
• Device Operator: Health Professional
• Device Model Number: SHOULDER IMPLANT
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/05/2023
• 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 Sex: Female