MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH EQUINOXE REVERSE SHOULDER LINER AND TRAY TORQUE DEFINING SCREW KIT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 320-20-00

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Loss of Range of Motion (2032)

Event Date 10/09/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 i had reverse shoulder replacement surgery at (b)(6) hospital by (b)(6) of (b)(6) using exactech equinoxe reverse shoulder components.I also had a tendon transfer which required the use of a gunslinger brace to immobilize the arm for 6 weeks.In (b)(6) 2020, while starting pt strengthening, i heard noise from the shoulder.X-rays showed that a mechanical failure of the humeral tray component.The tray had come loose from the humeral stem.Revision surgery was on (b)(6) 2020 at vhm.The operation report states " the liner was deemed to be loose without any significant broken fragments.No obvious signs of failure were noted, and it just appeared that the liner within the humeral tray component was dislodged and the screw holding the tray to the humeral stem was loose." the 0 mm liner and tray were replaced with a 2.5 mm liner and tray and a torque defining screw was used to secure the tray to the stem.The tray has not come apart since the revision operation.I noted that exactech had a recall in (b)(6) 2020 on the screw length of the glenosphere screws due to the wrong length.Is it possible that if the screw was too long that having a 0 mm liner would preclude a proper torque and that would be corrected by a 2.5 mm liner? before the revision operation i was advancing with my physical therapy and was able to lift my arm to about 110 degrees with a goal of 140 degrees in 10 months.Since the revision i cannot lift it beyond 90 degrees.The trauma to my anterior deltoid muscle due to having to a surgery so soon after the first one is obvious with the depression in my shoulder where it should be.No further surgery will correct it has this been reported or other cases similar? the serial numbers of the failed devices:humeral adaptor tray (b)(4), humeral liner (b)(4), fixed angle torque defining screw kit (b)(4).Fda safety report id # (b)(4).

• Brand Name: EXACTECH EQUINOXE REVERSE SHOULDER LINER AND TRAY TORQUE DEFINING SCREW KIT
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.
• MDR Report Key: 11435398
• MDR Text Key: 238858646
• Report Number: MW5099838
• Device Sequence Number: 1
• Product Code: KWT
• 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: 03/04/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 320-20-00
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 100