inforMED
InjuryHSH

IDUO G2

Received Mar 12, 2015

Report 3004153240-2015-00040 · MDR key 4606326

Device

Generic name

Bicompartmental Knee Replacement System

Manufacturer

Conformis, Inc.

Catalog number

UNK

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • No Code Available

Narrative

Description of Event or Problem

IT WAS REPORTED THAT REVISION SURGERY OCCURRED FOR PATIENT WITH A BICOMPARTMENTAL KNEE IMPLANT. REASON FOR REVISION IS UNKNOWN.

Additional Manufacturer Narrative

IT WAS REPORTED THAT REVISION SURGERY OCCURRED FOR PATIENT WITH A BICOMPARTMENTAL KNEE IMPLANT. REASON FOR REVISION IS UNKNOWN. DEVICE IDENTIFYING INFORMATION WAS NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE SERIAL NUMBER OF THE DEVICE WAS NOT REPORTED.