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

Model Number 320-42-00

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 11/10/2022

Event Type  Injury  

Manufacturer Narrative

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 impingement and revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition 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.It is known that a low lateral acromial angle and a large lateral extension of the acromion were associated with a higher prevalence of impingement and rotator cuff tears.Concomitant medical products: eq rev glenoid plate, 320-15-01, 7031403, eq rev locking screw, 320-15-05, 7253861, equinoxe reverse 42mm glenosphere, 320-01-42, 7063982, eq reverse torque defining screw kit, 320-20-00, 7265634, equinoxe, humeral stem primary, press fit 13mm, 300-01-13, 7042934, equinoxe reverse tray adapter plate tray +0, 320-10-00, 7106362.

Event Description

It was reported that this 64 y/o male patient's right shoulder had an impingement of the greater tuberosity on the acromion which had to be removed and inserted a new poly liner.The patient was not revised to exactech device.There were no reported issues during the revision procedure.The device will not be returned; it was disposed of by the hospital.Photos/x-ray were unable to be obtained.The patient was last known to be in stable condition following the event.Patient medical history/information was not available.No additional information.

• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16059586
• MDR Text Key: 306245869
• Report Number: 1038671-2022-01633
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/28/2022

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
• Device Operator: Health Professional
• Device Model Number: 320-42-00
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2021
• 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: 64 YR
• Patient Sex: Male