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

Model Number 3C98-3

Device Problem Unintended System Motion (1430)

Patient Problem Damage to Ligament(s) (1952)

Event Date 11/04/2022

Event Type  Injury  

Event Description

While walking the knee gave out; level walking; patient fell.Tore rotator cuff - necessitates med.Treatment.Noise - hissing / gurgling.Battery-/charging issue - battery charge does not last long.

Manufacturer Narrative

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

Event Description

While walking the knee gave out; level walking; patient fell and tore rotator cuff - necessitates med.Treatment.Noise - hissing / gurgling.Battery-/charging issue - battery charge does not last long.Further information received on 12/07/2022:medical treatment: put in sling (outpatient treatment).

Manufacturer Narrative

Further information received on 12/07/2022: medical treatment: put in sling (outpatient treatment) which resulted in a lower extent of damage and correction of health effect code (h6).

Event Description

While walking the knee gave out; level walking; patient fell.Tore rotator cuff - necessitates med.Treatment.Noise - hissing / gurgling.Battery-/charging issue - battery charge does not last long.Further information received on 12/07/2022: medical treatment: put in sling (outpatient treatment).

• 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: 15931126
• MDR Text Key: 304957888
• Report Number: 9615892-2022-00019
• 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,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• 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