BIOMET
Received Jun 11, 2004 · Event occurred Mar 25, 2004
Report 529954 · MDR key 529954
Device
Generic name
Total Shoulder Components/glenoid Poly Std Neer Ii
Manufacturer
Biomet, Inc.Model number
59394Catalog number
10810
Lot number
969500
Product problems
- Explanted
- Loose
- Other (for use when an appropriate device code cannot be identified)
Patient
71 YR
- Pain
- Other (for use when an appropriate patient code cannot be identified)
- Surgical procedure
Narrative
Description of Event or Problem
PT HAD A TOTAL RIGHT SHOULDER REPLACEMENT IN 2003. THEY HAVE HAD PERSISTENT PAIN IN THEIR RIGHT SHOULDER. THEY HAVE DECREASED RANGE OF MOTION AND DECREASED ACTIVITIES OF DAILY LIVING DUE TO THE PAIN. X-RAYS ARE POSITIVE FOR THE TOTAL SHOULDER ARTHROPLASTY WITH A HIGH-RIDING HUMERAL PROSTHESIS. THE PT WAS ADMITTED FOR REMOVAL FOR RIGHT TOTAL SHOULDER AND REVISION TO A REVERSE SHOULDER PROSTHESIS. DURING THE PROCEDURE THE SURGEON FOUND THE HUMERUS AND THE GLENOID COMPONENTS LOOSE. ALL COMPONENTS WERE REMOVED AND REPLACED.