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

Model Number 320-01-42

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0; 300-01-13, (b)(4) - equinoxe, humeral stem primary, press fit 13mm; 320-42-00, (b)(4) - equinoxe reverse 42mm humeral liner +0; 320-42-13, (b)(4) - equinoxe reverse 42mm humeral const liner +2.5; 320-15-04, (b)(4) - rs glenoid plate r post aug, 8 deg, right; 320-15-05, (b)(4) - eq rev locking screw; 320-20-00, (b)(4) - eq reverse torque defining screw kit.

Event Description

As reported, case originally done by surgeon in (b)(6).Approximately 3.5 yrs postop the right tsa this (b)(6) y/o male patient presented with pain and limited motion.X-rays show massive inferior notching, loose stem, metallosis and malpositioning of glenoid.Humeral liner was missing.A revision of the right shoulder was completed.The glenosphere and locking screw were changed with all humeral components removed and replaced with lima revision system.There was no breakage to device found.No other patient information or medical history reported.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

(h3) the revision reported was likely the result of humeral stem loosening and humeral liner disassociation, which led to the reported pain and limited range of motion.The humeral stem loosening was likely a result of an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.The humeral liner disassociation may have been the result of either incomplete seating of the liner during implantation, scapular notching, patient-related conditions, or any combination of these possibilities.The metal on metal contact between the humeral tray and glenosphere likely led to the reported metalosis.However, this cannot be confirmed as the devices were not available for evaluation.Section h11: *the following sections have corrected information: (d2b) common device name: reverse 42mm humeral const liner +2.5 (d4) catalog number: 320-42-13, serial number: (b)(6), expiration date: 26-jan-2022, unique identifier (udi) #: (b)(4).(d11) concomitant device(s): 320-10-00, 5460030 - equinoxe reverse tray adapter plate tray +0, 300-01-13, 5339173 - equinoxe, humeral stem primary, press fit 13mm, 320-42-00, 4506997 - equinoxe reverse 42mm humeral liner +0, 320-15-04, 5442223 - rs glenoid plate r post aug, 8 deg, right, 320-15-05, 5389263 - eq rev locking screw, 320-20-00, 5179533 - eq reverse torque defining screw kit, 320-01-42, 5309395 - equinoxe reverse 42mm glenosphere, (h4) device manufacture date: 30-jan-2017.

• 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: 13010543
• MDR Text Key: 287419808
• Report Number: 1038671-2021-00708
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2022
• Device Model Number: 320-01-42
• Device Catalogue Number: 320-42-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2017
• 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 Age: 70 YR
• Patient Sex: Male