MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG; EXTERNAL ABOVE KNEE PROSTHESIS

Model Number 3C98-3

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation in progress; supplemental report will be submitted after additional information has been obtained.

Event Description

Patient fell in church.The knee worked fine while the pt walked 3 blocks to church, and during mass, he was kneeling and standing.The knee suddenly dropped on him while he was walking in the church.He got help from others to stand up, and then immediately fell again.There was no resistance.He was helped to his truck, he drove about an hour and 10 min to the practitioner's office.Practitioner helped patient with getting in a wheelchair.He was wheeled in to assess the knee.No resistance whatsoever - practitioner charged the knee for about 20 minutes, then the knee again had resistance.He decided not to put the pt back on the knee, so he was put on a mechanical knee.The knee was put on the charger again for about an hour.The knee was put back on the pt while he was sitting and then it went back to no resistance.The knee never gave any warning signs.He was sent to urgent care, they did an mri and determined the shoulder needs to be replaced due to the damage.The rotator cuff was already damaged decades before, but healed.The fall made it where there is nothing doctors can do but to replace it.

Manufacturer Narrative

The investigation showed a mechanically damaged battery cable.This led to a loss of power supply and positioning of valves was not possible.The most likely cause of the event is a mechanically damage due to external force effect (user error).

• Brand Name: C-LEG
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• MDR Report Key: 7424520
• MDR Text Key: 105238593
• Report Number: 9615892-2018-00013
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C98-3
• Device Catalogue Number: 3C98-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 93