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

Catalog Number UNK_STM

Device Problems Loss of Osseointegration (2408); Migration (4003)

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

Event Date 10/01/2019

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.Note indicate "the patient is tall and still growing: shortening is 40-50 mm; previous pin 19063, surgery in (b)(6) 2014".Additional notes state "the overall replacement should cover the discrepancy; tibial spacer 15-20 mm; cemented femoral and tibial stems" update 25oct2019 - during the x-ray review, the clinician reported loosening and malposition of the femoral component.

Event Description

A patient specific prescription form was submitted for patient's right distal femur.Note indicate "the patient is tall and still growing: shortening is 40-50 mm; previous pin 19063, surgery in (b)(6) 2014".Additional notes state "the overall replacement should cover the discrepancy; tibial spacer 15-20 mm; cemented femoral and tibial stems." update 25oct2019 - during the x-ray review, the clinician reported loosening and malposition of the femoral component.

Manufacturer Narrative

Reported event: an event regarding loosening and varus migration of the femoral stem involving a jts distal femur was reported during x-ray review, therefore it was confirmed.Method and results: product evaluation and results: not performed as no items were received.Clinician review: the implant in situ was for a jts distal femoral replacement, which was inserted in (b)(6) 2014.The surgeon reported that the implanted leg is shorter than the normal leg by 40 to 50mm.The ct scans provided show that the implanted femur is 5 mm shorter that the normal femur and the implanted tibia is 20mm shorter than the normal tibia.Therefore, the total shortening is around 25mm, which in principle agrees with the clinical report.On the other hand, the implant has been extended by 80mm, which is nearly reached to its maximum capacity of 90mm.It was also noted that the femoral stem is very loose with a radiolucent line around the implant and the proximal femur has tilted in varus.The above 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 19dec2014 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01oct2016 to present for similar reported events regarding loosening and implant migration of the femoral stem involving jts distal femur.There have been 10 other events.Conclusions: the exact cause of the event could not be determined because further information such as patient's activity level, 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.Catalog numbers and lot codes of other devices listed in this report: smtbc02g (b12651 & b12993) tibial bearing; smcic01 (b13438) circlip; smbpr02 (b12842) bumper pad; smbsh02 (b12967) bushes.

• 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: 9249279
• MDR Text Key: 180441452
• Report Number: 3004105610-2019-00117
• 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: 12/03/2019

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: 06/30/2015
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 19063
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 YR