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

Model Number EQUINOXE REVERSE SHOULDER REPLACEMENT SYSTEM

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

Patient Problems Unspecified Infection (1930); Burning Sensation (2146); Insufficient Information (4580)

Event Date 07/01/2021

Event Type  Injury  

Event Description

As reported by u.S.Food & drug administration regulatory authority (mw5152566), the reported 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 prosthesis replaces in 2021 (right shoulder and left shoulder).Both of his shoulders were initially implanted with exactech equinoxe systems in 2019.Patient¿s left shoulder became infected approximately one month from first surgery starting with a burning sensation and required medication.Patient present shoulders systems includes a reverse configuration in his right shoulder and standard configuration on his left shoulder.Patient¿s left shoulder continues to have a burning sensation but presently with no infection.(reference report mw5152567).

Manufacturer Narrative

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

Manufacturer Narrative

H10.Additional/updated information.H6 health effect the unspecified infection and burning sensation are for reported left shoulder- clinical code & investigation conclusions h3.Investigation results- there is no specific equinoxe device information provided.The cause of the patient¿s subsequent revision as related to patient condition and the devices cannot be conclusively determined, due to reason not reported and insufficient information.There is no indication that the patient was revised to exactech devices in the procedure reported to be in 2021.The patient asked to remain confidential, there is no way to request additional information.There is no other information provided or available.These devices are used for treatment not diagnosis.

• Brand Name: EQUINOXE REVERSE SHOULDER REPLACEMENT SYSTEM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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
• MDR Report Key: 19164150
• MDR Text Key: 340831696
• Report Number: 1038671-2024-00947
• 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: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE SHOULDER REPLACEMENT SYSTEM
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Male