MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH MERIDIUM; EXTERNAL ANKLE/FOOT PROSTHETIC COMPONENT

Model Number 1B1=L27

Device Problem Unintended System Motion (1430)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 01/03/2022

Event Type  Injury  

Event Description

Incorrect joint behavior: foot does not hold forward resistance.Patient cannot tell if the fall happened because of a defect in the foot.Patient no longer wants the foot.Patient fell and broke neck of femur.The client fell and suffered a fracture of the neck of the femur.Patient fell while walking the dog outside.Foot beeped, buzzed and gave an error message.As said before, the patient is not sure if he fell because of the foot or possibly because of something else.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: MERIDIUM
• Type of Device: EXTERNAL ANKLE/FOOT PROSTHETIC COMPONENT
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• Manufacturer Contact: reinhard wolkerstorfer ; brehmstrasse 16; vienna, vienna 1110 ; AU 1110
• MDR Report Key: 13247200
• MDR Text Key: 283753552
• Report Number: 9615892-2022-00001
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1B1=L27
• Device Catalogue Number: 1B1=L27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2017
• 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
• Patient Sex: Male