MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; FRACTURE STEM

Catalog Number 304-21-07

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

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical devices: +0 humeral tray.+0 42 liner.42 glenosphere.Glenosphere locking screw.

Event Description

Primary surgery: 2013.Revision due to osteolysis, poly wear, and a loose humerus.Upon removal the stem was loose, and the poly showed some wear.

Manufacturer Narrative

Section h10: (b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged.(d4) catalog number: 304-21-07, serial number: (b)(6), unique identifier (udi) #: (b)(4).(e3) occupation: physician.(e4) initial reporter also sent report to fda?: no.(g5) pma/510(k)number: k092900 k101909.(h3) the revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the humeral stem.The reported wear was likely the result of scapular notching.(h4) device manufacture date: 02-mar-2012.(h6) evaluation codes: 1924, 4002.Section h11: the following sections have corrected information: (section f) please disregard f6 and f8 in previous report.These were entered in error.(g4) initial awareness date in initial submission should have been 05-jun-2019.

• Brand Name: EQUINOXE
• Type of Device: FRACTURE STEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8756309
• MDR Text Key: 149912158
• Report Number: 1038671-2019-00351
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 304-21-07
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/05/2019
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 62