inforMED
MalfunctionHSH

UNKNOWN PRODUCT - DURACON TIB INSERT

Received Sep 2, 2011 · Event occurred Aug 17, 2011

Report 9616680-2011-00577 · MDR key 2249901

Device

Generic name

Implant

Model number

NA

Catalog number

UNK

Lot number

UNK

Product problems

  • Naturally Worn

Patient

69 YR

  • No Code Available

Narrative

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT, "THE SURGERY WAS A REMOVAL OF A WORN DURACON T/K INSERT AND REPLACED WITH A NEW DURATION INSERT."

Remedial action

  • Other