InjuryIPG

OSSUR DH OFF LOADING POST OP SHOE

Received Nov 30, 2016 · Event occurred Nov 9, 2016

Report MW5066448 · MDR key 6140681

Device

Generic name

Healing Shoe

Manufacturer

Ossur

Model number

HCPC L3260

Product problems

Device Operates Differently Than Expected

Patient

66 YR

Bone Fracture(s)
Tissue Damage
Impaired Healing
Bone Fracture(s)
Tissue Damage
Impaired Healing

Narrative

Description of Event or Problem

TWISTED ANKLE (B)(6) 2016 NONDISPLACED FRACTURE OF LATERAL MALLEOLUS. OSSUR DH OFF LOADING POST OPERATIVE SHOE US PATENT #(B)(4), HCPC L3260 TOE CAP SEAM ABRASIVE PRESSURE RESULTED IN BLISTER; BLOOD FILLED NOTED ON (B)(6) 2016. PRODUCT DISCONTINUED (B)(6) 2016 AFTER MEDICATIONS TO REMOVE TOE CAP SEAM FAILED TO IMPROVE FOOL ULCER. OUTCOME: OSTEOMYELITIS, AMPUTATION OF 5TH METATARSAL AND 5TH TOE. THERAPY: (B)(6) 2016.