MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL HEAD, EXPANDED

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2017.Revision of right shoulder components due to a postero-sup rotator cuff tear and the glenoid becoming dislodged from the pegs.

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Postoperative rotator cuff tear is a known complication associated with total shoulder arthroplasty.Rotator cuff strains or tears are caused by overuse or acute injury.Revisions or surgical interventions are a known complication found in joint replacements.The cause of the postero-superior rotator cuff tear, with the polyethylene glenoid dislodged from the pegs is most likely related to the patient's underlying conditions.This device is used for treatment, not diagnosis.

Event Description

No addition information provided.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00266 and 1038671-2018-00692.

• Brand Name: EQUINOXE HUMERAL HEAD, EXPANDED
• Type of Device: HUMERAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7800883
• MDR Text Key: 117724389
• Report Number: 1038671-2018-00691
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 01/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 108