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

Catalog Number UNK_STM

Device Problem Failure to Advance (2524)

Patient Problem Cancer (3262)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

Reported event: an event regarding alleged seizing of a jts distal femur was reported.The event was not confirmed.Method and results: product evaluation and results: not performed as no items were returned.Clinician review: the implant in situ was a jts distal femoral replacement which was inserted in (b)(6) 2017.It was reported that the implant has failed to extend from beginning.The x ray provided shows that there is a very small gap of extension for the device, which indicates that the implant has not been extended.Therefore, the radiographic assessment can support the clinical report.Product history review: review of the product history records indicate (b)(4) devices was manufactured and accepted into final stock on 08dec2017 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01jan2017 to present for similar reported events regarding seizing involving jts distal femur.There have been 2 other events.Conclusions: 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

It has been reported that the patient's jts implant is not extending.

• 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
• 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: 9817268
• MDR Text Key: 189991762
• Report Number: 3004105610-2020-00054
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 21070
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2017
• 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): Other
• Patient Age: 13 YR