MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 46MM HUMERAL CONST LINER +0

Model Number	320-46-10
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
Patient was working out and stretching when he felt something happen in his shoulder.When doctor went and completed the surgery, he noticed that the humeral liner had become disassociated from the humeral adapter tray.
Additional Manufacturer Narrative
(b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged.(d4) expiration date: 29-mar-2021.(e3) occupation: physician.(e4) initial reporter also sent report to fda?: no.(g5) pma/510(k)number: k063569.(h3) the revision reported was likely the result of incomplete seating of the humeral liner in the humeral adapter tray, which may have been the result of retained biological matter on the locking button feature of the humeral liner, combined with bone impingement due to the patient¿s above average physical activity level, which led to disassociation of the humeral liner from the humeral adapter tray.(h4) device manufacture date: 05-apr-2016.(h6) evaluation codes: 1924, 2923.The following sections have corrected information: (b5) an 82 y/o, 5ft 11in, 192-pound male patient underwent implantation of an equinoxe on (b)(6) 2018.The patient is reported to be very active and works out in the gym regular; however, no heavy weight lifting.In (b)(6) 2019 the patient was working out and stretching when he felt ¿something happen in his shoulder¿.Two days later he saw the doctor and an x-ray revealed disassociation of the humeral liner.On (b)(6), the patient underwent revision surgery to replace the humeral adapter tray and liner to allow the patient to return to his activities of daily living.(section f) please disregard f6 and f8.These were entered in error.(g4) date received by manufacturer ¿ date on initial submission should have been 11-apr-2019.
Event or Problem Description
An 82 y/o, 5ft 11in, 192-pound male patient underwent implantation of an equinoxe on (b)(6) 2018.The patient is reported to be very active and works out in the gym regular; however, no heavy weight lifting.In (b)(6) 2019 the patient was working out and stretching when he felt ¿something happen in his shoulder¿.Two days later he saw the doctor and an x-ray revealed disassociation of the humeral liner.On (b)(6), the patient underwent revision surgery to replace the humeral adapter tray and liner to allow the patient to return to his activities of daily living.

• Brand Name: EQUINOXE
• Common Device Name: EQUINOXE REVERSE 46MM HUMERAL CONST LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8659489
• Report Number: 1038671-2019-00316
• Device Sequence Number: 14022027
• Product Code: KWT
• UDI-Device Identifier: 10885862086754
• UDI-Public: 10885862086754
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2021
• Device Model Number: 320-46-10
• Device Catalogue Number: 320-46-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Distributor Facility Aware Date: 05/13/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 04/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 87