MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE TOTAL FEMUR MINIMALLY INVASIVE GROWER (MIG); LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problem Activation Problem (4042)

Patient Problem Injury (2348)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding alleged failure to extend involving a total femur mig was reported.The event was confirmed.Method and results product evaluation and results: visual inspection - visual inspection identified visual damage to the device coating and the gear-wheel has minor damage to the ends of the gear teeth.Functional inspection - the device as returned to siw is non functional.Material analysis: not performed as event is not related to material.Clinician review: x-ray review.The affected implant for total femur mig was inserted (b)(6) 2012 and has been reported by the surgeon that the implant has reached maximum extension.The x-ray shows the existing minimally invasive growing implant has not been extended since implantation.Due to the growth of the patient is apparent the leg length is now shorter.The reason for the revision has not been confirmed.Product history review: review of the device history record indicate one device was manufactured and accepted into final stock on 28 feb 2012, with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 2015 to present for similar reported events regarding seizing.There have been no other events.Conclusions: investigation indicates that the device does not appear to have extended since implantation.The device was returned with damage to the gear wheel and with the gear wheel reversed into a position that did not contact fully with the extension screw.When the gear wheel of the returned device was turned to the correct position the device was found to be fully functional.Investigation indicates that the worm has been rotated in the incorrect direction and the screw has bottomed out in the piston.The damage observed to the ends of the teeth of the gear wheel would be a result of this.The instructions for adjustment provided for the user of the implant include instructions on the correct direction to rotate the extension screw and also provide instruction for the user to ensure the gearbox mechanism is properly engaged when assembling the implant.The exact cause of the event could not be determined because further information such as the primary operative report as well as patient history and follow up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as insufficient information was received by siw.If additional information become available to indicate further evaluation is warranted, this record will be re-opened.Siw will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.Please note: the reported device is similar to a total femur mig device approved for compassionate use in the united states.

Event Description

A new revision request has been received due to a total femur minimally invasive grower (mig) not extending.

• Brand Name: TOTAL FEMUR MINIMALLY INVASIVE GROWER (MIG)
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer Contact: margaret foley ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 8079031
• MDR Text Key: 127536223
• Report Number: 3004105610-2018-00135
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 16851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 19 YR