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

Patient Problems Purulent Discharge (1812); Erythema (1840); Hematoma (1884); Failure of Implant (1924); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032)

Event Date 02/25/2021

Event Type  Injury  

Event Description

Reporter calling to report problems after her husband received two equinoxe shoulder system replacements, each for his left shoulder.Reporter states the surgeon was "dr.(b)(6) at (b)(6).Telephone (b)(6)." reporter states her husband had initial shoulder replacement surgery on (b)(6) 2021, and came down with an infection almost immediately after implant.Reporter states her husband continually communicated to the surgeon that he was having pain in his shoulder and that it wasn't feeling right, however the surgeon dismissed that anything was wrong.Reporter states that this process continued for two months before the surgeon's office believed that there was an infection.Reporter states that on (b)(6) 2021, as she was rubbing pain-relieving cream on her husband's shoulder that she noticed a "bright red, puffy, swollen lump, about 3 inch by 3 inch in size" on her husband's shoulder.Reporter states a ct (computed tomography) scan was performed in (b)(6) 2021, which showed infection.Reporter states a "50 cc syringe" of pus was drained from this lump, and when the pa (physician's assistant) applied slight pressure, pus and fluid squirted out on to her uniform.Reporter states surgery was performed on (b)(6) 2021, and all shoulder components were removed except for the shoulder ball, and additionally states the shoulder site was thoroughly washed out before a new equinoxe device was again implanted.Reporter states her husband was prescribed doxycycline at that time and continues with that prescription today.Reporter states that after this replacement surgery, her husband continued to experience pain, and limited range of motion in the left shoulder.Reporter states that on (b)(6) 2024, x-rays showed broken screws in the equinoxe shoulder system and an explant procedure was once again performed.Reporter states that on (b)(6) 2024, the surgical incision site developed a hematoma and required medical attention.Reporter states in approximately january 2024, she received a notification on her cell phone that the equinoxe shoulder system was "under fda recall" and states they learned her husband's two equinoxe shoulder systems were part of this recall."model numbers: 320-20-34, 320-20-26, 320-20-22, 320-15-05, 320-20-00, 300-01-11, 320-38-00, 320-10-15".Reference report: mw5152511.

• Brand Name: EQUINOXE SHOULDER SYSTEM
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.
• MDR Report Key: 18873747
• MDR Text Key: 337438919
• Report Number: MW5152512
• 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: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: DOXYCYCLINE; TOPICAL PAIN CREAM
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male