MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE SHOULDER REPLACEMENT SYSTEM - RIGHT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Patient Problems Unspecified Infection (1930); Burning Sensation (2146)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Reporter called to report that he received a letter from exactech notifying him that both of his shoulder implants may be subject to product quality issues that may pose health risks.Reporter had both equinoxe shoulder prostheses replaced in 2021 (right shoulder in (b)(6) and left shoulder in (b)(6)).Both of his shoulders were initially implanted with exactech equinoxe systems in (b)(6) 2019.His left shoulder became infected approximately one month from first surgery starting with a burning sensation and required medication.Reporters present shoulder systems includes a reverse configuration in his right shoulder and a standard configuration in his left shoulder.His left shoulder continues to have a burning sensation but presently with no infection.Reference report: mw5152567.

• Brand Name: EQUINOXE REVERSE SHOULDER REPLACEMENT SYSTEM - RIGHT
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.
• MDR Report Key: 18876388
• MDR Text Key: 337571211
• Report Number: MW5152566
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/08/2024

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2024
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male