MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 46 NEUTRAL HUMERAL LINER

Catalog Number	320-46-03
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation concomitant device(s): 300-30-06, 03066166 - equinoxe preserve stem 6mm +0 adapter tray.320-02-46, 292248010 - 46x21mm glenosphere high moment arm.
Event or Problem Description
It was reported the liner disassociated from the humeral tray causing the (b)(6) male patient's shoulder to dislocate.The surgeon revised the left side glenosphere to a 42+4.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
(d4) catalog number: 320-46-03, serial number: (b)(6), expiration date: 02-jun-2025, 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 liner during implantation, bone impingement, patient-related conditions, or any combination of these possibilities, which led to humeral liner disassociation followed by dislocation.However, this cannot be confirmed as the devices were not returned for evaluation and x-rays were not provided.(h4) device manufacture date: 04-jun-2020 section h11: the following sections have corrected information: (d11) concomitant device(s): 300-30-06, 6591180 - equinoxe preserve stem 6mm.320-02-46, 6480692 - 46x21mm glenosphere high moment arm.320-10-00, 6623446 - equinoxe reverse tray adapter plate tray +0.

• Brand Name: EQUINOXE
• Common Device Name: 46 NEUTRAL HUMERAL LINER
• 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: 12646583
• Report Number: 1038671-2021-00542
• Device Sequence Number: 1309116
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• 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): 05/10/2022

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: 06/02/2025
• Device Catalogue Number: 320-46-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 110 KG