MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 46MM HUMERAL LINER +2.5

Model Number	EQUINOXE REVERSE 46MM HUMERAL LINER +2.5
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: equinoxe reverse glenosphere, 46mm (cn: 320-01-46; sn: (b)(4)); equinoxe reverse glenoid plate (cn: 320-15-01; sn: (b)(4)); equinoxe humeral stem, primary, press-fit, 17mm (cn: 300-01-17; sn: (b)(4)), equinoxe reverse tray adapter plate tray, +5 (cn: 320-10-04; sn: (b)(4)); equinoxe reverse torque defining screw (cn: 320-20-00; sn: (b)(4)); equinoxe reverse locking screw (cn: 320-15-05; sn: (b)(4)); equinoxe reverse compression screw/locking cap kit, 4.5 x 22mm (cn: 320-20-22; sn: (b)(4)); equinoxe reverse compression screw/locking cap kit, 4.5 x 26mm (cn: 320-20-26; sn: (b)(4)); equinoxe reverse compression screw/locking cap kit, 4.5 x 18mm (cn: 320-20-18; sn: (b)(4)); equinoxe reverse compression screw/locking cap kit, 4.5 x 26mm (cn: 320-20-26; sn: (b)(4)).
Event or Problem Description
In 2017 patient had a reverse left shoulder replacement with exactech components.In late 2018 the plastic cup between the two metal elements came out.The plastic cup came out while patient was doing physical therapy for right shoulder traditional replacement (also exactech components).
Additional Manufacturer Narrative
Section h10: (b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged.(d4) expiration date: 07-mar-2021.(d6) if implanted, give date: on (b)(6) 2017.(d7) if explanted, give date: on (b)(6) 2019.(d11) concomitant medical products and therapy dates.(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 either incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), complete wear of the liner, or a combination of the three, which led to the liner disassociating from the humeral tray.However, this cannot be confirmed because the devices were not available for evaluation.(h4) device manufacture date: 08-mar-2016.(h6) evaluation codes: 1924, 2923.Section h11: the following sections have corrected information: (b3) date of event: on (b)(6) 2019.(d4) model number: na.(section f) please disregard f6 and f8.These were entered in error.(h1) type of reportable event: serious injury.(h5) labeled for single use?: yes.

• Brand Name: EQUINOXE
• Common Device Name: EQUINOXE REVERSE 46MM HUMERAL LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8649510
• Report Number: 1038671-2019-00294
• Device Sequence Number: 11347968
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2021
• Device Model Number: EQUINOXE REVERSE 46MM HUMERAL LINER +2.5
• Device Catalogue Number: 320-46-03
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/03/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention