MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR MIG; LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding alleged subluxed short axle involving a mig distal femur was reported.The event was not confirmed.Method and results: device evaluation and results: visual inspection - visual inspection identified that the axle of the assembled device, as returned, was not fully inserted to the correct depth into the recess of the tibial component.Visual inspection identified damage to the rim of the recess of the tibial component on both sides.Visual inspection identified damage to the rotation holes of the axle head.Visual inspection identified surface scratches and damage to the femoral component and the tibial component.Dimensional inspection - the device is dimensionally within specification.Functional inspection - the functional inspection indicates that the head of the axle cannot be correctly inserted into the recess of the tibial component due to the damage to the rim of the tibial component axle recess.The device is non-functional.Medical records received and evaluation: review of video and still images provided by healthcare facility: review of the video clip provided shows that when the axle is flush with the tibial component the other side of the axle is almost touching the hinge hole, which indicates that the length of the axle is appropriate.The axle then needs to be rotated to be fully seated, however, this didn't show in the video clip.From the patient history provided by the healthcare facility, it states that the original axle and tibial component was inserted in 2013 (pin (b)(4)).We need the surgical record (which has been requested) to show that the in the original surgery it was inserted successfully and according to the surgical technique provided by siw.Review of the device history record indicate one device was manufactured and accepted into final stock on 31-oct-2013, with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 2012 to present for similar reported events regarding subluxed short axle.There has been no other event.Conclusions: the investigation concluded that the device is dimensionally within specification.The rim of the axle recess of the tibial component has been damaged to an extent that prevents the axle from being fully inserted into the axle recess.The exact cause of the event could not be determined because further information such as post-operative ex-rays, 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, this investigation 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 distal femur mig device approved for compassionate use in the united states.

Event Description

It has been reported that during a debridement and exploratory surgery on (b)(6) 2018 the axle had subluxed.It has been further reported by the surgeon that the axle is too short.

• Brand Name: DISTAL FEMUR 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: 8078906
• MDR Text Key: 127543505
• Report Number: 3004105610-2018-00131
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 18242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 18 YR