MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD CUSTOM JTS NON-INVASIVE DISTAL FEMUR REPLACEMENT IMPLANT; LIMB SALVAGE SYSTEM

Model Number BME18175

Device Problems Labelling, Instructions for Use or Training Problem (1318); Insufficient Information (3190)

Patient Problems No Code Available (3191); Cancer (3262)

Event Date 10/28/2014

Event Type  malfunction  

Event Description

The patient was diagnosed with bone tumour of the left distal femur and underwent a procedure with a stanmore custom minimally invasive grower distal femur replacement implant in (b)(6) 2008.Between 2009 and 2013, the patient underwent multiple lengthening procedures.In early 2014, the surgeon revised the minimally invasive prosthesis to be a non-invasive grower while keeping the original tibial component in situ.The patient underwent successful non-invasive leg lengthening procedures using a reusable grower unit in early 2014.However, it was reported that the distal femur implant did not appear to lengthen during two leg lengthening procedures that occurred on (b)(6) 2014.

Manufacturer Narrative

The investigation is ongoing.A preliminary investigation for the complaint revealed that the company did not provide the distributor with the grower drive instructions for use (ifu) when the reusable unit was initially shipped to the distributor.Consequently, the distributor did not provide the facility with an ifu for the grower drive unit.This document was recently supplied to the distributor who has restrained its sales team.Capa (b)(4) has been initiated and the distributor has been issues a scar (supplier corrective action #064-14).A supplemental report will be provided.This custom jts distal femur replacement implant is similar jts extendible distal femoral implant (k133152).

Manufacturer Narrative

The investigation concluded that the root cause of this event was due to a manufacturing issue.On initial receipt of the reported event, the event description was reviewed and with the limited information available at that time, a decision was made to report the event.However on completion of the investigation into the reported event it can now be concluded that the incident does not meet the three basic reporting criteria referenced in 21 cfr part 803 as a marketed device did not cause or contribute to a death or serious injury, or a marketed device has not malfunctioned where the malfunction of the device or a similar marketed device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Product surveillance will continue to monitor for trends.

Event Description

The patient was diagnosed with bone tumour of the left distal femur and underwent a procedure with a stanmore custom minimally invasive grower distal femur replacement implant in (b)(6) 2008.Between 2009 and 2013, the patient underwent multiple lengthening procedures.In early 2014, the surgeon revised the minimally invasive prosthesis to be a non-invasive grower while keeping the original tibial component in situ.The patient underwent successful non-invasive leg lengthening procedures using a reusable grower unit in early 2014.However, it was reported that the distal femur implant did not appear to lengthen during two leg lengthening procedures that occurred on (b)(6) 2014.This is a supplemental report to 30040105610-2014-00051 (b)(4).

• Brand Name: CUSTOM JTS NON-INVASIVE DISTAL FEMUR REPLACEMENT IMPLANT
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD; 210 centennial avenue; centennial park; elstree, WD6 3 SJ; UK WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE LTD; 210 centennial avenue; centennial park; elstree, WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 4319668
• MDR Text Key: 5213476
• Report Number: 3004105610-2014-00051
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2014
• Device Model Number: BME18175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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: 10 YR