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 08/25/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information according to user report (bfarm): event with significant consequences.No further information known according to the event.Overall, prosthesis seems to be ok.Damage to the electronic knee joint cannot be excluded.Information according to the complaint file: user fell while walking down the stairs in front of the physiotherapy practice.Whether the fall happened because of the joint cannot be said currently (no witnesses).User lies in hospital with injuries.The type of injuries are still unknown.Joint is still functioning and has full damping after a brief check at the healthcare professional.The user is still in the hospital and is currently struggling with pneumonia and sepsis, which he fall ill in the hospital, so that the technician cannot reach the user at the moment.The wife does not get in touch again until the user comes into rehab.According to the technician the joint was also properly installed so that the fall was probably not caused by the joint, it also works perfectly, according to mr.(b)(6).The only thing he can say is that the user came to the hospital due to a head injury.

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, vienna 1110 ; AU 1110
• MDR Report Key: 10606562
• MDR Text Key: 209202054
• Report Number: 9615892-2020-00010
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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: 09/10/2020
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Weight: 98