inforMED
OtherHSH

OPTETRAK LOGIC

Received Aug 20, 2013

Report 1038671-2013-00115 · MDR key 3313598

Device

Generic name

Posterior Stabilized Tibial Insert

Manufacturer

Exactech, Inc.

Catalog number

02-012-35-3009

Lot number

18321520

Product problems

  • Device Slipped

Patient

Not reported

  • No Code Available

Narrative

Description of Event or Problem

REVISION OF KNEE COMPONENT DUE TO LOOSENING.

Additional Manufacturer Narrative

RETURNED DEVICES ARE CURRENTLY UNDERGOING ENGINEERING EVAL.