MalfunctionHSH
UNKNOWN PERSONA TASP SHIM INSTRUMENT
Received Oct 17, 2014
Report 1822565-2014-01415 · MDR key 4196622
Device
Generic name
Knee Instrument
Manufacturer
Zimmer, Inc.Product problems
- Detachment Of Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT IS REPORTED THAT THE BALL BEARINGS WERE FOUND IN THE ULTRA SONIC WASH SEPARATED FROM THE TRIAL ARTICULAR SURFACE PROVISIONAL SHIMS.
Additional Manufacturer Narrative
OTHER DEVICE USED: CATALOG #UNK, PERSONA TRIAL ARTICULAR SURFACE PROVISIONAL SHIM, LOT #UNK - QUANTITY 4. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.