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

Catalog Number 320-06-38

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: humeral stem or stemless 3003008.Reverse humeral liner 3203800.Reverse humeral tray 3201000.Reverse glenosphere baseplate 3201501.

Event Description

It was reported via clinical study that the 62 yo male patient experienced re-occurring dislocations due to shoulder instability.The date of event onset is (b)(6) 2023.The patient will undergo revision surgery in the near future with recommendations to convert to larger glenosphere for improved shoulder stability.The outcome was last known as continuing.

• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17451772
• MDR Text Key: 320317270
• Report Number: 1038671-2023-01807
• Device Sequence Number: 1
• Product Code: KWS
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-06-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White