MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE JTS TOTAL FEMUR; LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problems No Device Output (1435); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Cancer (3262)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device not available.

Event Description

It was reported that the patient's jts implant did not extend as expected.The extension of another patient's implant was successful on the same day therefore it was reported that there is no issue with the jts drive unit.The jts drive unit is used to extend the device.

Event Description

It was reported that the patient's jts implant did not extend as expected.The extension of another patient's implant was successful on the same day therefore it was reported that there is no issue with the jts drive unit.The jts drive unit is used to extend the device.

Manufacturer Narrative

Reported event an event regarding alleged failure to extend involving a jts total femur was reported.The event was confirmed.Method and results device evaluation and results: visual inspection the external surface of the returned device has visible surface marks and discoloration on the femoral component and the shafts.There is no visible gap at the join between the shaft sections.When the piston was initially removed from the shaft the tip of the output shaft square drive was observed to have broken off and was loose within the shaft.Dimensional inspection: not performed as reported issue is functional not dimensional.Functional inspection: the device was inserted into the magnet test jig and it was audibly confirmed that the motor was operating.However, the jts total femur was not observed to be extending during a 5-minute test.The returned device is non-functional.Material analysis not performed as reported issue is functional, not material.Medical records received and evaluation: x ray review - this is the jts total femoral replacement which was inserted in 2017.The image provided shows that no extension has been made.The reason behind the claimed issue regarding lengthening of the implant is unknown, therefore further investigation is required should the implant be returned.Therefore, the reason for revision has been radiographically confirmed.Device history review: review of the device history records indicate one device was manufactured and accepted into final stock on 11 jan, 2017 with no reported discrepancies.Complaint history review: based on the device identification the complaint data bases were reviewed from 01 may 2016 to present for similar reported events regarding seizing.There have been no other events reported.Conclusions: a lengthening procedure was attended by an siw design engineer in june 2017 who reported that the gearbox sounded good but no extension was shown on the x-ray and the prosthesis did not grow.The device was subsequently explanted and returned to siw in december 2018.The investigation of the returned device concluded that it is most likely that the device extension mechanism was initially operated by the user in the incorrect direction, this resulted in the mechanism becoming jammed closed instead of extending as intended, the absence of a gap at the join between the shaft sections indicates that the device may have been operated in reverse.Continuing to attempt to use the device in the incorrect direction may have resulted in the implant extension motor straining against an immovable jam and the torque produced could eventually damage the output shaft square drive rendering the extension mechanism non functional.Instruction on the direction the drive unit should be used is included in the lengthening protocol and operation manual and the operation drawing provided with the implant.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Siw will continue to monitor for trends.No action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: JTS TOTAL FEMUR
• 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
• MDR Report Key: 6614525
• MDR Text Key: 76748568
• Report Number: 3004105610-2017-00037
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K092138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 19828
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR