MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL LONG STEM

Model Number EQUINOXE, HUMERAL LONG STEM 8MM 175MM

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Revision due to dislocation.Patient showed up to dr.With a painful reverse shoulder.X-rays revealed a dislocated reverse, which could not be a closed reduced so an open reduction was booked.During surgery, it was decided to remove liner and tray, but the stem loosened when removing humeral adaptor tray.A trial stem was inserted and a new tray/liner trailed.Once surgeon was happy the definitive implants were put in place, shoulder was reduced, and surgeon expects patient to recover well.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of loosening supporting ligaments and muscles, which allowed for dislocation.However, this cannot be confirmed as the explants were not available for evaluation.

• Brand Name: EQUINOXE HUMERAL LONG STEM
• Type of Device: STEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 7978746
• MDR Text Key: 124134724
• Report Number: 1038671-2018-00811
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE, HUMERAL LONG STEM 8MM 175MM
• Device Catalogue Number: 306-01-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/16/2018
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR