MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM

Catalog Number 300-01-10

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2019.Revision due to cage glenoid disassociating from the pegs without any traumatic event.

Manufacturer Narrative

Section h10: (b2) added check for "hospitalization - initial or prolonged" (d4) expiration date: 102-feb-2028, unique identifier (udi) #: (b)(4).(g1) mdr reporting contact name: (b)(6).(g5) pma/510(k)number: k042021.(h3) the revision reported may have been the result of the glenoid component bottoming out on the glenoid wall upon implantation, possibly related to the small glenoid anatomy, which led to splaying of the posterior inferior peg and ultimate failure.However, the surgeon stated that the patient experienced failure of the rotator cuff which may have led to instability and, as a result, shear stress on the glenoid.Because the explanted device was not returned to exactech for evaluation and no additional x-ray images were provided, specifically an axillary view, it is not possible to determine the underlying cause for this case.(h4) device manufacture date: (b)(6) 2018.*no information provided in the following section(s): a1, a2, a3, a4, a5, b6, b7, e3, g8, h6, h7.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8311634
• MDR Text Key: 135206088
• Report Number: 1038671-2019-00067
• 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
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-01-10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention