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

Device Problem Material Deformation (2976)

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that a 53 yo male patient, initial left shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2024, approximately 11 months post the initial procedure.The patient was revised due to shoulder pain and instability.Once patient was opened up, it was noticeable that the poly was flattened down quite a bit, and that the patient had been subluxing for a while due to his shoulder being loose.The stem was well fixated and left in place.The stem did subside a little bit.Poly was distorted from subluxation.Patients +0 mm tray and 42mm +0 liner were replaced with a +10 mm tray and 42mm +0 liner.The humeral implants were replaced except for the stem.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.The explanted devices are not available for return as the hospital won¿t release them.No x-rays or device images were able to be obtained.No further information.

• Brand Name: EQUINOXE
• 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: matt collins ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19072089
• MDR Text Key: 339777789
• Report Number: 1038671-2024-00764
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male