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

Lot Number BME18215

Device Problems Defective Component (2292); Packaging Problem (3007)

Patient Problems No Known Impact Or Consequence To Patient (2692); Cancer (3262)

Event Date 11/04/2013

Event Type  malfunction  

Event Description

A company representative reported that during a jts extendible distal femoral implant, the surgeon determined that the femoral stem was 1 cm too long thus used a midas rex during the procedure to remove the extra 1 cm.Additionally, the device packaging appeared to be damaged when handled by the surgeon.The surgery was successfully completed without incident.During the procedure, the surgeon also noted that a femoral planer should be provided to allow surgeons to smooth out and contour the mid-shaft femur due to concerns regarding the proximity of the femoral artery.The representative in attendance during the procedure noted that a custom axle rotation tool would be helpful to minimize a surgeon's frustration.

Manufacturer Narrative

The complaint investigation is ongoing.A supplemental report will be provided.

Manufacturer Narrative

An x-ray review was performed by (b)(6) - jts product specialist & senior design engineer which concluded that - the reported over-sized stem of the prosthesis was not confirmed.Assessing where the tip of the stem would sit if it had not been cut off i can conclude that the prosthesis and the stem would have fitted the patient without the tip being cut.The tip of the stem would have been close to the physis but there is space for the stem and cement without impinging/destroying this growth plate.The exact root cause of the event could not be determined because insufficient information was provided.Requests were made for further information in relation to this incident however the requested information was not provided to stanmore implants (siw).Further information such as product return, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The complaint is being closed and tracked and trended.Corrected data- distal femur extendible implant corrected to limb salvage system.Pma# - 510k corrected from k092138 to k133152.

Event Description

A company representative reported that during a jts extendible distal femoral implant, the surgeon determined that the femoral stem was 1 cm too long thus used a midas rex during the procedure to remove the extra 1 cm.Additionally, the device packaging appeared to be damaged when handled by the surgeon.The surgery was successfully completed without incident.During the procedure, the surgeon also noted that a femoral planer should be provided to allow surgeons to smooth out and contour the mid-shaft femur due to concerns regarding the proximity of the femoral artery.The representative in attendance during the procedure noted that a custom axle rotation tool would be helpful to minimize a surgeon's frustration.This is a supplemental report to 3004105610-2014-00010 ((b)(4)).

• Brand Name: JTS NON-INVASIVE EXTENDIBLE DISTAL FEMUR
• 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 Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 4176873
• MDR Text Key: 5087313
• Report Number: 3004105610-2014-00010
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2014
• Device Lot Number: BME18215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 8 YR