MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE, HUMERAL LONG STEM 8MM 175MM

Catalog Number 306-01-08

Device Problems Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Humeral liner.

Event Description

It was reported that the primary surgery occurred on (b)(6) 2017.The patient has had a revision due to aseptic humeral loosening.Extreme pain in shoulder due to humeral loosening and non-union.

Manufacturer Narrative

Section h10: (d4) catalog number: 320-10-00, serial number: (b)(6) , expiration date: 01-may-2027, unique identifier (udi) #: (b)(4).(g5) pma/510(k)number: k063569.(h4) device manufacture date: 02-may-2017.(h6) evaluation codes: 1924, 4002.Section h11: the following sections have corrected information: (d1) common device name: reverse tray adapter plate tray +0 (d11) concomitant device(s): equinoxe reverse 42mm humeral liner +0 (cn: 320-42-00 / sn: (b)(6)).

Manufacturer Narrative

The revision reported was likely the result of an insufficient bond between the implant and the bone and patient conditions, which led to aseptic (non-infected) humeral loosening, pain, and non-union.However, this cannot be confirmed as the explanted devices were not available for evaluation.The following sections have corrected information: (b5) as reported, approximately 18 months postop the initial tsa, this 52 y/o female complained of extreme pain in shoulder due to aseptic humeral loosening and non-union.The case report form indicates this event was resolved with revision surgery on (b)(6) 2018 and indicates this event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.(d1) common device name: equinoxe, humeral long stem 8mm 175mm.(d4) catalog number: 306-01-08, serial number: (b)(6) , expiration date: 02-apr-2022, unique identifier (udi) #: (b)(4).(d11) concomitant device(s): 320-10-00, 4875737, equinoxe reverse tray adapter plate tray +0.320-42-00, 4361319, equinoxe reverse 42mm humeral liner +0.320-20-00, 4852547, eq reverse torque defining screw kit.(g5) pma/510(k)number: k042021.(h4) device manufacture date: 02-apr-2012.

Event Description

As reported, approximately 18 months postop the initial tsa, this 52 y/o female complained of extreme pain in shoulder due to aseptic humeral loosening and non-union.The case report form indicates this event was resolved with revision surgery on (b)(6) 2018 and indicates this event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE, HUMERAL LONG STEM 8MM 175MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9207639
• MDR Text Key: 170494631
• Report Number: 1038671-2019-00522
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2022
• Device Catalogue Number: 306-01-08
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 122