MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE GMBH MODULAR EBS KNEE JOINT

Model Number 3R60

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

Several bolts are used to fix the different parts of the knee joint when it is mounted.The threads of the bolts are covered with an two-component-adhesive, which is hardening once the bolt is tightened.This is to assure that the parts are fixed permanently.The visual evaluation was carried out on 10/06/2015.It showed that the adhesive did not harden correctly.Therefore the bolt in the upper part (backward, right hand side) disengaged and fell out of the joint.Internal investigation is going on to determine the root cause.

Event Description

Knee joint was sent in for repair because the bolt fell out of the side.No fall, no injury.Patient did not experience any type of event related to the malfunction.

• Brand Name: MODULAR EBS KNEE JOINT
• Type of Device: MODULAR EBS KNEE JOINT
• Manufacturer (Section D): OTTO BOCK HEALTHCARE GMBH; max-naeder-str. 15; duderstadt, niedersachsen 37115 ; GM 37115
• Manufacturer (Section G): OTTO BOCK HEALTHCARE GMBH; max-naeder-str. 15; duderstadt, niedersachsen 37115 ; GM 37115
• Manufacturer Contact: dominik schmidt ; max-naeder-str. 15; duderstadt, niedersachsen 37115 ; GM 37115 ; 9552784816
• MDR Report Key: 5153020
• MDR Text Key: 28743842
• Report Number: 9616494-2015-00004
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3R60
• Device Catalogue Number: 3R60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2015
• 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