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

Catalog Number UNK_STM

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Cancer (3262)

Event Date 10/16/2019

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.Clinician review: the implant in situ was for mets distal femoral replacement, which was inserted in (b)(6) 2019 (informed by rep).The surgeon now would like to change to jts distal femoral replacement because the patient is in more steady conditions.The imaging provided shows that distal femoral implant in situ with the resection level at lesser trochanter and the stem has been bended towards the femoral neck.The stem is well positioned and fixed and no abnormal signs have been observed.Therefore, the revision of this implant is purely based on clinical judgment.Device not returned.

Event Description

This patient had a real aggressive osteosarcoma a few months ago and the surgeon decided to use a mets df with a non-conventional use: as you can see, he completely modified the femoral stem.The patient prognosis was critical at this time.Now the prognosis is more safe for this young patient, so he would like to make a new surgery with a jts df.Mets components used are small size.He will leave the tibial component in place.

Manufacturer Narrative

On initial receipt of the reported event, the event description was reviewed and with the limited information available at that time, a decision was made to report the event.Upon investigation there is no allegation against the device in situ which was implanted as a temporary measure due to the state of the patient's health.The event is therefore not reportable.

Event Description

This patient had a real aggressive osteosarcoma a few months ago and the surgeon decided to use a mets df with a non-conventional use: as you can see, he completely modified the femoral stem.The patient prognosis was critical at this time.Now the prognosis is more safe for this young patient, so he would like to make a new surgery with a jts df.Mets components used are small size.He will leave the tibial component in place.

• Brand Name: METS DISTAL FEMUR
• 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: 9488561
• MDR Text Key: 176998351
• Report Number: 3004105610-2019-00135
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K121029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 9 YR