MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); Cancer (3262)

Event Date 02/17/2020

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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Device not returned.

Event Description

A complaint form was provided reporting the following: "patient presented with local recurrence of osteosarcoma.Original diagnosis: left proximal tibia osteosarcoma.Current medical status: otherwise normal, given the fact that he has had multiple recon procedures on that limb.Device: jts proximal tibia, minimally invasive extendible distal femur." spoke to reporter.A custom implant will be revised to off-the-shelf total femur (gmrs) components when a suitable combination is found that will work.Required by date is asap.There are no allegations against the in situ devices.

Manufacturer Narrative

Reported event: an event regarding patient factors, osteosarcoma re-occurrence.Involving a jts, distal femur was reported.The event was not confirmed.Methods and results: device evaluation and results: not performed as no device failure was reported.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on (b)(6) 2015 with no reported discrepancies complaint history review: based on the device identification the complaint databases were reviewed from (b)(6) 2017 to present for similar reported events regarding patient factors, osteosarcoma, re-occurrence.There have been 4 other events.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Other devices listed in this report: proximal tibia replacement pin 20277 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

A complaint form was provided reporting the following: "patient presented with local recurrence of osteosarcoma.Original diagnosis: left proximal tibia osteosarcoma.Current medical status: otherwise normal, given the fact that he has had multiple recon procedures on that limb.Device: jts proximal tibia, minimally invasive extendible distal femur." spoke to reporter.A custom implant will be revised to off-the-shelf total femur (gmrs) components when a suitable combination is found that will work.Required by date is asap.There are no allegations against the in situ devices.

• Brand Name: DISTAL FEMUR JTS
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• MDR Report Key: 9834888
• MDR Text Key: 183905972
• Report Number: 3004105610-2020-00063
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 19398
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 04/08/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR