MAUDE Adverse Event Report: CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT; DISTAL FEMUR IMPLANT

Model Number BME18850

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/12/2015

Event Type  malfunction  

Event Description

During a custom jts distal femur replacement procedure the surgeon experienced difficulty fitting the rotating hinge tibial component into the tibial baseplate and stem that were in situ.He was unable to get the implant to seat correctly.A second rotating hinge tibial component was used which was implanted without any complication.The second component selected appeared to be shorter than the first component that was used.

Manufacturer Narrative

The device was returned and reviewed along with pictures that were provided by the sales representative.The design team member who designed the prosthesis reviewed the returned information.It was clear that the first component that was tried was part of the mark 4 (upgraded) components and the base plate and stem that were in situ were mark 3 components.The second component that was subsequently implanted was also a mark 3 component.All femoral components are compatible with the both the mark 3 and mark 4 tibial components, so there is no concern with the functionality of the replacement.During the design phase a review of a patient's previous procedures is carried out to note any implants they may already have in situ to ensure that the compatibility is considered.In this case, the review was not carried out effectively.Upon review of the case a design review sheet is completed.The process of reviewing the old patient files will now be recorded as part of this process, so this should ensure there are no further occurrences of this nature.

• Brand Name: CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT
• Type of Device: DISTAL FEMUR IMPLANT
• Manufacturer Contact: sian rogers ; elstree WD6 3-SJ ; UK WD6 3SJ ; 082386500
• MDR Report Key: 4688973
• MDR Text Key: 21834266
• Report Number: 3004105610-2015-00035
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/04/2015
• Device Model Number: BME18850
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR