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

Model Number 3C98-3

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Type  Injury  

Event Description

Routine service: but customer said the patient fell.However, he doesn't know if it was because of the knee or if he just fell.(b)(6) had no information about this event.He was walking through his rv and fell.We don't know if it was caused by the knee or not.I was told this is a routine check and as far as (b)(6) knows there is nothing wrong with it.

Manufacturer Narrative

Device is currently not available for evaluation; supplemental report will be submitted after evaluation of all device components is completed.

Event Description

Routine service: but customer said the patient fell.However, he doesn't know if it was because of the knee or if he just fell.Chad had no information about this event.He was walking through his rv and fell.We don't know if it was caused by the knee or not.I was told this is a routine check and as far as chad knows there is nothing wrong with it.The practitioner doesn't have any more information.When he first called he said their was a fall but then he told me the patient didn't have the device on when he fell.He doesn't know why he fell and he didn't give me a malfunction of the device.He just didn't have a lot of information for me and now he has even less.

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: 15975448
• MDR Text Key: 305414122
• Report Number: 9615892-2022-00020
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2019
• 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
• Patient Sex: Male