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

Catalog Number UNK_STM

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646); Cancer (3262)

Event Date 12/05/2019

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.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 patient specific prescription form was submitted for patient's right distal femur and proximal tibia.Diagnosis is "loosening of the tibial stem".Note indicate "ewing sarcoma operated in 2015 loosening of tibial stem and residual leg length discrepancy revision needed of tibial stem and distal femur with a new lengthening mechanism".Additional notes state "a revision of the distal femoral, the femoral stem is needed but i would like to keep the femoral stem, the plate and collar in-situ and change the new component that will couple with this metalwork." as per email on the 05dec2019 "the tibial stem is going into valgus and is become painful.I measure a lengthening of 53mm and the discrepancy is more than 2cm at this moment.".

Manufacturer Narrative

Reported event: an event regarding alleged loosening involving a jts distal femur was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as no items were returned.Clinician review: a review of the provided x-rays by clinical consultant indicated: the implant in situ was for a jts distal femoral replacement which was inserted on (b)(6) 2015.The surgeon reported loosening and valgus tilt of the tibial stem and a leg length discrepancy.The x ray provided has shown that the tibial stem has titled valgus which indicating that the stem has loosened inside the cavity.The tilt of the stem tip has caused the bone defect on the lateral side of the tibia cortex.The stem has been extended by 52mm which is shorter than its maximum capacity of 65mm.Also, measured from the x ray provided that the effected leg is shorter than the opposite leg, therefore, the radiographic assessment can confirm the reason for revision.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 12 aug 2015 with no reported discrepancies, complaint history review: based on the device identification the complaint databases were reviewed from (b)(6) 2016 to present for similar reported events regarding tibia stem / component, loosening.There have been 6 other events.Conclusions: an event regarding alleged loosening involving a jts distal femur was reported.The surgeon also reported a progressive migration of the tibial stem into valgus position and pain.The exact cause of the event could not be determined because brief description.For example further information such as 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 no devices and/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.

Event Description

A patient specific prescription form was submitted for patient's right distal femur and proximal tibia.Diagnosis is "loosening of the tibial stem".Note indicate "ewing sarcoma operated in 2015 loosening of tibial stem and residual leg length discrepancy revision needed of tibial stem and distal femur with a new lengthening mechanism".Additional notes state "a revision of the distal femoral, the femoral stem is needed but i would like to keep the femoral stem, the plate and collar in-situ and change the new component that will couple with this metalwork." as per email on the 05dec2019 - "the tibial stem is going into valgus and is become painful.I measure a lengthening of 53mm and the discrepancy is more than 2cm at this moment.".

• 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: 9502796
• MDR Text Key: 173191464
• Report Number: 3004105610-2019-00141
• 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,other
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 19569
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 11 YR