MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 38MM GLENOSPHERE

Catalog Number 320-01-38

Device Problem Mechanical Problem (1384)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-15-01, (b)(4), eq rev glenoid plate; 320-15-05, (b)(4), eq rev locking screw.

Event Description

As reported, two years post shoulder implant, the patient woke up with almost no ability to move her right arm and with pain and patient did not do any unusual activity or suffered from any hit.Patient approached a shoulder orthopedic expert, who x-ray her, and to physician understanding patient faces a technical failure between the glenoid and the baseplate.The device will not be returned for evaluation.

Manufacturer Narrative

If explanted, give date: (b)(6) 2019.Occupation: physician.Pma/510(k)number: k063569.Device manufacture date: 16-dec-2016.

Event Description

New information received that revision has occurred sometime in august.No other new information available at this time.

Manufacturer Narrative

Section h10: (h3) the revision reported may have been the result of misaligning the glenosphere on the glenoid baseplate during the initial surgery, which may have prevented the glenosphere locking screw from fully seating.The incomplete seating scenario likely caused the glenosphere locking screw to carry most of the joint loading and resulted in the glenosphere locking screw¿s threads becoming stripped and allowing for the screw to backout of the baseplate.However, this cannot be confirmed as the devices were not available for evaluation.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 38MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8930203
• MDR Text Key: 189073627
• Report Number: 1038671-2019-00420
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 01/23/2020; 02/06/2020
• Supplement Dates FDA Received: 01/29/2020; 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention