InjuryHSH

IFORMA

Received Nov 2, 2018 · Event occurred Oct 1, 2018

Report 3004153240-2018-00243 · MDR key 8032293

Device

Generic name

Knee Interpositional Device

Manufacturer

Conformis, Inc.

Catalog number

M57210600010

Product problems

Adverse Event Without Identified Device or Use Problem

Patient

53 YR

Pain
Ambulation or Postural Difficulties
Pain
Ambulation or Postural Difficulties

Narrative

Additional Manufacturer Narrative

PATIENT "REPORED" DISC FAILURE, IMMOBILITY AND PAIN. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT DEVICE WAS MANUFACTURED TO SPECIFICATION.

Description of Event or Problem

PATIENT "REPORED" DISC FAILURE, IMMOBILITY AND PAIN. REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS.