MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM

Catalog Number 300-01-11

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to glenoid loosening.

Manufacturer Narrative

The revision reported may have been the result of off-center contact between the glenosphere and the humeral liner, which led to aseptic (non-infected) loosening of the glenoid baseplate.However, this cannot be confirmed because the explants were not available for evaluation.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8282557
• MDR Text Key: 134255805
• Report Number: 1038671-2019-00038
• 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
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention