MAUDE Adverse Event Report: DJO, LLC PROCARE NEXTEP CONTOUR WALKER,MEDIUM; ORTHOSIS, LIMB BRACE

Model Number 79-95065

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Necrosis (1971)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

Instructions for use state "warning: this product is to be used under the supervision of a medical professional.This device is not intended for unsupervised public use.If you experience any pain, swelling, sensation changes, or any unusual reactions while using this product, consult your medical professional immediately." these instructions were not followed.No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the patient experienced necrosis of the foot, leading to amputation of the leg, in association with wearing the device.He initially bumped his foot, resulting in a lot of pain, on the night of (b)(6) 2018.He was taken by taxi to the hospital, where an x-ray confirmed a fracture of the fifth metatarsal of his left foot.He was prescribed a walking boot, which was not available at the pharmacy to which the taxi took him.The pharmacy took the dimensions of his foot.On (b)(6) 2018, the taxi brought the nextep contour boot from the pharmacy and the boot was placed on the patient by the taxi driver.Shortly thereafter, the patient felt great pain.He subsequently went biweekly to a psychotherapy center and left the boot on day and night from (b)(6) 2018.The patient went to the hospital on (b)(6) 2018 for a foot examination.When the orthosis was removed, the left ankle and foot were found to be "flayed alive" and necrotic.He subsequently stayed at home with nursing care every two days to redo the bandage.After 20 days, the nurse could not treat the foot any more; the condition of which had worsened and the tendon was bare.The patient was hospitalized from (b)(6) 2018 to (b)(6) 2019.When he was discharged, he received daily care.Part of the ankle and foot were healed, but the heel was hollowed out and not healed.He was hospitalized again in dermatology from (b)(6) 2019 with a check-up on (b)(6) 2019.He was sent home in a wheelchair.The patient's condition subsequently worsened and he was admitted to the emergency room on (b)(6) 2019, where the result of the computed tomography (ct) scan showed that the calcaneum was fractured and there was an infection.He was at great risk of sepsis, and it was decided to amputate his leg.The operation was successfully performed on (b)(6) 2019.

• Brand Name: PROCARE NEXTEP CONTOUR WALKER,MEDIUM
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c. 22244 ; MX 22244
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, tx
• MDR Report Key: 9823861
• MDR Text Key: 193088196
• Report Number: 9616086-2020-00010
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 79-95065
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability