inforMED
InjuryISS

LINER PROTECT 3C 28 MTRX 10

Received Aug 2, 2017

Report 3006221031-2017-00001 · MDR key 6761286

Device

Generic name

Prosthetic Liner

Manufacturer

Ossur Bayreuth

Model number

MC97128

Catalog number

MC97128

Product problems

  • Loose or Intermittent Connection

Patient

78 YR

  • Fall
  • Injury
  • Fall
  • Injury

Narrative

Description of Event or Problem

BELOW KNEE AMPUTEE PATIENT WAS WEARING A PROTECT PROSTHETIC LINER AND CLAIMS THE PIN CAME LOOSE FROM THE LINER CAUSING HIM TO FALL RESULTING IN A BROKEN FOOT ON HIS SOUND SIDE.

Additional Manufacturer Narrative

PRODUCT EVALUATION ONGOING - WILL FOLLOW-UP WITH A SUPPLEMENTAL REPORT TO INCLUDE PRODUCT EVALUATION.

Description of Event or Problem

BELOW KNEE AMPUTEE PATIENT WAS WEARING A PROTECT PROSTHETIC LINER AND CLAIMS THE PIN CAME LOOSE FROM THE LINER CAUSING HIM TO FALL RESULTING IN A BROKEN FOOT ON HIS SOUND SIDE.