MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE GMBH AQUA KNEE

Model Number 3WR95

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

Based on the information provided the patient failed to lock the knee and fell.No complaint against the device.The end-user admittedly reported failing to manually lock the knee when standing up to change positions during a family photo session.This is a new user and this is her first prosthesis.The use error has led to a serious injuries that required surgical intervention.In the instruction for use it is stated how to handle the locking function and that there is a risk when failing the locking function.The mistake made by the person who has used the device was the sole cause of the incident.Therefore, reporting to the authorities would be required at this time, based on the available information.(b)(4).

Event Description

Pt was taking family photos, was in a sitting position, when she stood up to move positions, patient failed to manually lock the knee, fell over and broke her femur bone.Surgery due to incident: pt had emergency surgery to reinforce femur with a titanium rod.

• Brand Name: AQUA KNEE
• Type of Device: AQUA KNEE
• Manufacturer (Section D): OTTO BOCK HEALTHCARE GMBH; max-naeder-str. 15; duderstadt, 37115 ; GM 37115
• Manufacturer (Section G): OTTO BOCK HEALTHCARE GMBH; max-naeder-str. 15; duderstadt, 37115 ; GM 37115
• Manufacturer Contact: dominik schmidt ; max-naeder-str. 15; duderstadt, 37115 ; GM 37115
• MDR Report Key: 9817114
• MDR Text Key: 182992405
• Report Number: 9616494-2017-00052
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3WR95
• Device Catalogue Number: 3WR95
• Device Lot Number: 0001201240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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; Other