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

Model Number 3C98-3

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Limb Fracture (4518)

Event Date 12/31/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Incorrect joint behaviour: battery charging problem, no charging.Fall with fracture of right arm (plaster and x-ray).

Manufacturer Narrative

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

• Brand Name: C-LEG
• Type of Device: EXTERNAL KNEE 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: 13252089
• MDR Text Key: 283767847
• Report Number: 9615892-2022-00003
• Device Sequence Number: 1
• Product Code: ISY
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 01/19/2022
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 83 KG