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

Catalog Number UNK_STM

Device Problem Osseointegration Problem (3003)

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

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding loosening of a femoral component involving a jts distal femur was identified during x-ray review.Method and results: product evaluation and results: not performed as no items were returned.Clinician review: the implant in situ was for a jts distal femoral replacement which was inserted in (b)(6) 2016.The surgeon reported the maximum extension of the implant.The ct scan provided showed that the implant has been extended by 90mm which has not reached to its maximum capacity of 110mm.Therefore, one more extension is required before the maximum extension.In addition, the radiolucent lines between the cement mantle and the bone along the femoral stem has been observed.Therefore, the radiographic assessment can confirm in part the clinical report.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 30nov2015 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01jan2016 to present for similar reported events regarding loosening in femoral stem of jts distal femur.There have been 12 other events.Conclusions: an event regarding loosening of a femoral component involving a jts distal femur was identified during x-ray review.The exact cause of the event could not be determined because 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.Device not returned.

Event Description

During the x-ray review to investigate muscle contracture (mfr ref #3 004105610-2019-00132) it was observed there was loosening of the femoral stem.

• Brand Name: DISTAL FEMUR JTS - FEMORAL STEM
• 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
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 9780463
• MDR Text Key: 183738820
• Report Number: 3004105610-2020-00042
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: RU
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• 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: PIN 19802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 13 YR