MAUDE Adverse Event Report: ZIMMER BIOMETVBB / ZIMMER BIOMET ZIMMER TM REVERSE SHOULDER WITH 12MM TM REVERSE HUMERAL STEM 36MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/12/2018

Event Type  Injury  

Event Description

Additional surgery, fracture; i had a zimmer reverse shoulder replacement removed at (b)(6) clinic in (b)(6).During removal, the glenoid was broken in 3-5 pieces, and a month later it was discovered that my scapula had been broken in 2.I had a 10" fracture with 1" displacement.A piece of the screw also broke off and is still in my shoulder.I had surgery to repair the scapula fracture on (b)(6) 2019.I had 2 plates and 20+ screws put in my scapula.There is still a fracture at the top of the scapula and the glenoid is still broken.The metal screw part is still in my shoulder.Fda safety report id# (b)(4).

• Brand Name: ZIMMER TM REVERSE SHOULDER WITH 12MM TM REVERSE HUMERAL STEM 36MM GLENOSPHERE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER BIOMETVBB / ZIMMER BIOMET
• MDR Report Key: 10211732
• MDR Text Key: 197140235
• Report Number: MW5095277
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 58 YR
• Patient Weight: 120