MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-BRACE JOINT UNIT; KNEE ORTHOSIS

Model Number 17KO1=R

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Physical Resistance/Sticking (4012)

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

Event Date 08/19/2022

Event Type  Injury  

Event Description

Patient reports brace not yielding properly when they fell.Patient felt the brace did not yield when he was falling.Stumble recovery/yielding does not work.Patient fell while wearing the orthosis on (b)(6) 2022.As a result of the fall they fractured their right proximal femur.The patient reported that they felt the brace did not yield as expected when falling.Fracture to right proximal femur requiring surgical treatment.Surgical repair to right proximal femur scheduled (b)(6) 2022.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event.

Event Description

Patient reports brace not yielding properly when they fell.Patient felt the brace did not yield when he was falling.Stumble recovery/yielding does not work.Patient fell while wearing the orthosis on (b)(6) 2022.As a result of the fall they fractured their right proximal femur.The patient reported that they felt the brace did not yield as expected when falling.Fracture to right proximal femur requiring surgical treatment.Surgical repair to right proximal femur scheduled (b)(6) 2022.Further information from 29.10.2022: as far as we are aware following conversations with the client, we do not believe the fall was as a result of a failure of the device and the client is unable to clarify that this is so.

• Brand Name: C-BRACE JOINT UNIT
• Type of Device: KNEE ORTHOSIS
• 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: 15631341
• MDR Text Key: 301986633
• Report Number: 9615892-2022-00012
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 17KO1=R
• Device Catalogue Number: 17KO1=R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2022
• 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): Required Intervention; Hospitalization
• Patient Weight: 85 KG