MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG

Model Number 3C88-3

Device Problem Device Handling Problem (3265)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 09/14/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event.

Event Description

Patient walked in to the house, through the hall and entered the lounge and his leg just gave way underneath him.His wife didn't see it as she was in the kitchen.She heard a shout and a bang, so rushed in to see what had happened and the patient was laid on his side on the floor with his prosthetic leg kind of underneath him.She asked him what had happened and he said "i don't know! my leg just buckled underneath me." he wasn't doing anything unusual but just walking through as he has done for 40 years.Further information received on 21.11.2019: taken to (b)(6) hospital where they x rayed his leg and found that he had suffered a peri prosthetic fracture to his left femur, just above the end of the dsf implant.Patient has direct skeletal fixation to his left trans-femoral amputation stump.On (b)(6) patient was transferred to (b)(6) hospital as they had a surgeon who would be better able to deal with the break.Patient had an operation to fix the break on thursday (b)(6) where the surgeon screwed, pinned and plated the femur.He was in (b)(6) recovering before coming home on the (b)(6).

• Brand Name: C-LEG
• Type of Device: C-LEG
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• Manufacturer Contact: reinhard wolkerstorfer ; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• MDR Report Key: 9457172
• MDR Text Key: 186825684
• Report Number: 9615892-2019-00018
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C88-3
• Device Catalogue Number: 3C88-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2018
• 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