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

Model Number 3C98-1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Intracranial Hemorrhage (1891); Skull Fracture (2077); Concussion (2192); Loss of consciousness (2418)

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

Device is currently not available for evaluation (not returned from the customer yet); device was not in for service for 5 years (last service 05-2012); supplemental report will be submitted after evaluation of all device components is completed.

Event Description

Client had fallen, he hit his head and was hospitalized.Client collapsed and was injured.He came in from outdoors, turned to reach behind him to close the door.Still wearing boots.Backed up and fell somehow, twisting to avoid falling down the stairs.Unsure if leg collapsed or tripped? clients c-leg is 8 years old (date of purchase: (b)(6) 2009) and has not been serviced since may 31, 2012.Information regarding injuries: client reports severe concussion, lengthy period of unconsciousness, subsequent diagnosis of cranial fracture in the temporal area, with hematoma (brain hemorrhage), cervical fracture at c6.He was taken by ambulance to hospital, where he stayed for several days (one month).

Manufacturer Narrative

The device was evaluated by the service department and the product refinement engineering department.Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the reported fall.Related to the reported event the device operated within specification.

• Brand Name: C-LEG KNEE JOINT
• Type of Device: EXTERNAL ABOVE KNEE PROSTHESIS
• 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 ; 1 5233786
• MDR Report Key: 6662679
• MDR Text Key: 78230089
• Report Number: 9615892-2017-00017
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C98-1
• Device Catalogue Number: 3C98-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2009
• 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; Life Threatening; Required Intervention
• Patient Weight: 104