ZIMMER REVERSE SHOULDER REPLACEMENT
Received Sep 5, 2019 · Event occurred Nov 12, 2018
Report MW5089608 · MDR key 8970801
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal / Polymer Cemented
Manufacturer
Zimmer, Inc.Product problems
- Patient-Device Incompatibility
Patient
58 YR
- Bone Fracture(s)
- Pain
- Bone Fracture(s)
- Pain
Narrative
Description of Event or Problem
I HAD A ZIMMER REVERSE SHOULDER REPLACEMENT PLACED (B)(6) 2016. IN (B)(6) 2017 I DEVELOPED WARMTH IN MY SHOULDER AND ARM AND SEVERE PAIN AND ELEVATED CRP AND ESR. I HAD THE SHOULDER REMOVED AT (B)(6) CLINIC ON (B)(6) 2018. (B)(6) PERFORMED AN OSTEOTOMY AND WINDOW IN MY HUMERUS TO REMOVE THE STEM. MY GLENOID WAS BROKEN IN 3-5 PIECES TO REMOVE THE BASE. IN (B)(6) 2019, XRAYS SHOWED A SCAPULA FRACTURE. A CT SCAN IN (B)(6) 2019 SHOWED A HUGE SCAPULA FRACTURE CAUSED BY THE REMOVAL OF THE SHOULDER. I HAD A 10" SCAPULA FRACTURE WITH 1-2" DISPLACEMENT. THIS REQUIRED SURGERY AND 2 PLATES AND 23 PLATES WERE PLACED TO PULL THE FRACTURE TOGETHER. FDA SAFETY REPORT ID# (B)(4).