MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-46-00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this (b)(6) male patient's right shoulder was revised due to his humeral liner becoming disassociated from the humeral tray sometime after primary surgery.Surgeon removed the stem, tray, and liner.Date of revision is unknown and initial implant date is unknown.Patient was last known to be in stable condition following the event.Devices will be returning.
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 320-10-00, 66378004 - equinoxe reverse tray adapter plate tray +0 15mm stem - s/l 03113741.
Additional Manufacturer Narrative
(d4) catalog number: 320-46-00, serial number: (b)(6), expiration date: 02-mar-2019, unique identifier (udi) #: (b)(4).(g4) pma/510(k)number: k063569.(h3) the revision reported may have been the result of either incomplete seating of the humeral liner, humeral tray, and/or torque screw during implantation, bone impingement, patient-related conditions such as high bmi, backside wear, or any combination of these possibilities, which led to humeral liner disassociation.(h4) device manufacture date: 04-mar-2014 section h11: the following sections have corrected information: (d1) brand name: equinoxe reverse 46mm humeral liner +0 d2b) common device name: prosthesis, shoulder, non-constrained, metal/polymer cemented (d10) concomitant device(s): 300-01-15, 3891212 - equinoxe, humeral stem primary, press fit 15mm, 320-10-00, 4023807 - equinoxe reverse tray adapter plate tray +0 320-20-00, 4029229 - eq reverse torque defining screw kit.(h6) component code: 4755; part/component/sub-assembly term not applicable.

• Brand Name: EQUINOXE REVERSE 46MM HUMERAL LINER +0
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 13769965
• Report Number: 1038671-2022-00257
• Device Sequence Number: 4104566
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2019
• Device Model Number: 320-46-00
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 128 KG