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

Model Number EQUINOXE SHOULDER

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

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 10/01/2023

Event Type  Injury  

Event Description

As reported by the u.S food & drug administration authorities (ref# mw5151155), the reporter called and stated ¿she had left shoulder replacement surgery and experienced joint dislocation beginning in approximately 2023.She stated that the dislocation has occurred three separate times since 2023.She reported that her surgeon¿s office recently sent her a letter of an fda safety alert regarding this equinoxe shoulder device and defective bags.The reported states that she is scheduled for an additional surgery on her left shoulder on 2024 and states the surgery may possible be a revision procedure if her surgeon cannot fix the current device.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

• 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: michael crader
• MDR Report Key: 18919029
• MDR Text Key: 337843786
• Report Number: 1038671-2024-00527
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE SHOULDER
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• 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