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

Catalog Number UNK_STM

Device Problems Use of Device Problem (1670); Failure to Advance (2524)

Patient Problems No Known Impact Or Consequence To Patient (2692); Cancer (3262)

Event Date 10/08/2019

Event Type  malfunction  

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

It was reported "i urgently to be put in contact with engineering department according to the case with pin 19826 a jts implanted in bologna last (b)(6) 2015.Today during an elongating session today the implant seems to be locked at 50 mm while surgeon wanted to go for another 20mm.".

Event Description

It was reported "i urgently to be put in contact with engineering department according to the case with pin 19826 a jts implanted in bologna last (b)(6) 2015.Today during an elongating session today the implant seems to be locked at 50 mm while surgeon wanted to go for another 20mm." 19nov19 update - jts pin 19826 was successfully extended today when boosted on power setting 3.

Manufacturer Narrative

Reported event: an event regarding an failure of extension involving a jts distal femur was reported.The event was confirmed by x ray review.Method and results: product evaluation and results: visual inspection: not performed as the device remains implanted.Dimensional inspection: not performed as the device remains implanted.Functional inspection: not performed as the device remains implanted.Material analysis: not performed as the device remains implanted.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 the (b)(6) 2015.The surgeon reported that the implant has locked at 50mm during extension.However, a recent report has shown that the stem has been extended to satisfactory with a different setting instructed by the design office.The imaging provided shows that the implant has been extended by 50 mm which is shorter than its maximum capacity of 70 mm which can confirm the first incidence that the surgeon has reported.No further imaging was provided for assessing the recent extension.Therefore, the radiographic assessment can confirm the clinical report.Product history review: review of the product history records indicates 1 device was manufactured and accepted into final stock on 26 nov 2015 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01-jan-2016 for similar reported events regarding jts distal femur seizing.There have been 3 other events.Conclusions: the investigation concluded that the power setting on the jts drive unit needed to change to extend the implant successfully.From the information received by the sales rep, we can confirm the implant was successfully extended when the jts drive unit was boosted to power setting 3.During the prior lengthening procedure, the unit remained at power setting 0.No further investigation for this event is possible at this time as no devices and insufficient information was received by siw.If devices and additional information become available to indicate further evaluation is warranted, this record will be re-opened.

• 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: 9281828
• MDR Text Key: 189991119
• Report Number: 3004105610-2019-00119
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 19826
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR