AS INVERSE GLENOID FIXATION
Received Jul 22, 2009 · Event occurred Apr 24, 2009
Report 9613350-2009-00337 · MDR key 1424135
Device
Generic name
Anatomica Glenoid Component
Manufacturer
Zimmer GmbhCatalog number
01.04223.200
Lot number
UNK
Product problems
- Failure to Osseointegrate
Patient
71 YR
- Surgical procedure, repeated
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PT WILL BE REVISED DUE TO NO BONY INGROWTH ON THE IMPLANT BACKSIDE OF THE GLENOID.
Additional Manufacturer Narrative
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. ASSOCIATED COMPONENTS: PRODUCT NAME: A.S. HUMERAL STEM 10.5 UNCEMENTED, REF NUMBER: 01.04201.102, LOT NUMBER: 2331017. INVERSE/REVERSE SCREW SYSTEM, 4.5-18, 01.04223.018, UNK. INVERSE/REVERSE SCREW SYSTEM, 4.5-36, 01.04223.036, UNK. AS INVERSE HUMERAL CUP, OFF CENTER, 01.04223.106, 2339898. AS INVERSE GLENOID HEAD 36, 01.04223.236, UNK.