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

Model Number 3C98-3

Device Problem Device Handling Problem (3265)

Patient Problems Fall (1848); Injury (2348)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient fall - knee did not extend.Her 24mth serviced unit was only returned to her in february this year.Patient reports that the c-leg failed to 'follow through' whilst walking in the kitchen recently, resulting in a significant fall, requiring hospitalization.

Event Description

Patient fall - knee did not extend.Her 24mth serviced unit was only returned to her in february this year.Patient reports that the c-leg failed to 'follow through' whilst walking in the kitchen recently, resulting in a significant fall, requiring hospitalization.Unit reported as making a "zooming noise".Prosthetist confirms "knee" is not bending when walking and needs to be pushed into place when sitting.

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 ABOVE KNEE PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• MDR Report Key: 8508152
• MDR Text Key: 141724682
• Report Number: 9615892-2019-00006
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• 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: 08/22/2019
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization