MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL LINER +0

Model Number 320-42-00

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 05/09/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical device(s): 320-15-05, (b)(4), eq rev locking screw.

Event Description

As reported, approximately 9 months postop the initial implant, the (b)(6) y/o patient presented for the postoperative check of the left shoulder.Upon exam, it was noted that the locking screw had backed out somehow.A revision was scheduled and completed.The locking screw and humeral liner were replaced.Patient was last known to be in stable condition following the event.Devices disposed of by hospital.

Manufacturer Narrative

The revision reported may have been the result of not properly aligning the glenosphere relative to the glenoid baseplate during the initial surgery.This misalignment likely prohibited the glenosphere from fully seating and the glenosphere locking screw from fully engaging the glenoid baseplate, resulting in disassembly of the glenosphere locking screw.However, this cannot be confirmed as the explants were not available for evaluation.Section h11: the following sections have corrected information: (d4) catalog number: 320-15-05, serial number: (b)(6), expiration date: 07-jul-2024, unique identifier (udi) #:(b)(4).(d11) concomitant device(s): 320-42-00, 6090294 - equinoxe reverse 42mm humeral liner +0.(h4) device manufacture date: 10-jul-2019 (h6) evaluation code: 3165, 2907.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10060718
• MDR Text Key: 191080548
• Report Number: 1038671-2020-00293
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-42-00
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR