MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL CONST LINER +2.5

Model Number 320-42-13

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 10/14/2021

Event Type  Injury  

Event Description

As reported, approximately 14 months postop the initial rtsa, this (b)(6) male patient was lifting boards over his head and the poly disassociated.The patient was revised to the same size implants, except for the humeral adapter plate tray, which was upsized to a +5 and an extra screw (38mm) that was implanted in the glenoid plate.Patient was last known to be in stable condition following the event.Devices will not return due to facility policy.

Manufacturer Narrative

Pending evaluation: concomitant device(s): 320-02-42, 6057913 - rs expanded glenosphere 42mm +4; 320-10-00, 6474250 - rs adapter plate tray; 320-15-05, 6412829 - rs locking screw; 320-20-00, 6482360 - rs torque screw kit.

Manufacturer Narrative

Section h10: h3: the revision reported may have been the result of either incomplete seating of the liner during implantation, bone impingement, patient-related conditions, a post-traumatic event involving lifting boards overhead, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot confirmed as the devices were not returned for evaluation and x-rays were not provided.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM HUMERAL CONST LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12770096
• MDR Text Key: 280453523
• Report Number: 1038671-2021-00588
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2021
• Device Model Number: 320-42-13
• Device Catalogue Number: 320-42-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male