MAUDE Adverse Event Report: BIOMET GLENOSPHERE

Model Number 670960

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374)

Event Date 09/06/2016

Event Type  Injury  

Event Description

I had a right reverse shoulder replacement on (b)(6) 2016 for severe nonrepairable chronic rotator cuff tear.On (b)(6), (b)(6) 2016, while eating lunch, i lifted the fork from my plate to my mouth.I heard a loud pop, then i started having severe right shoulder pain.Since it was a holiday weekend, i went home and used ice and pain meds until i could see my surgeon, dr (b)(6) , on monday, (b)(6) 2016.He took x-rays and a mri.The mri showed dislocation of the glenoid sphere from the glenoid fixation device.I was scheduled for another right reverse shoulder replacement on (b)(6) 2016.During the surgery the surgeon found the glenosphere to be loose and according to the operative report, the central screw in the baseplate was slightly prominent.He replaced the glenosphere.He also tightened the central screw two additional turns so it was flat against the baseplate.After the second right shoulder replacement i had four weeks of physical therapy two times a week.Now i have very limited movement of my arm and shoulder.The surgeon said he made sure that the parts would not come apart again, but i think it's over-tightened and i will never be able to use it like i had before the first surgery.

• Brand Name: GLENOSPHERE
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): BIOMET
• MDR Report Key: 6876028
• MDR Text Key: 86749586
• Report Number: MW5072208
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/16/2017

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 670960
• Device Catalogue Number: 115310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 140