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

Catalog Number JTS-COIL

Device Problems No Device Output (1435); Output Problem (3005)

Patient Problem Cancer (3262)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

Please note that this event is related to a jts drive unit which is used in conjunction with the jts non-invasive extendible implant (k092138).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.

Event Description

It was reported the patient's jts distal femur implant underwent a series of very irregular lengthening events.

Manufacturer Narrative

Please note that this event is related to a jts drive unit which is used in conjunction with the jts non-invasive extendible implant (k092138).Reported event: an event regarding non functioning jts drive unit was reported.The event was confirmed by product inspection.Method and results: product evaluation and results: visual inspection - pictures of the jts power unit, jts coil and cables were taken.Visual inspection of the jts power unit reported that minor signs of damage were found on the upper and lateral surfaces.Moreover, the label reporting the latest annual maintenance was missing.The jts coil showed minor scratches on the lateral side.Cables did not show any visible damage.Functional inspection - not performed as the item was returned damaged.Product history review: review of the inspection records reported that the jts drive unit passed the annual maintenance on the (b)(6) 19 without discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from (b)(6) 2017 to present for similar events regarding jts drive unit not functioning.There have been 6 similar events.Conclusions: an event regarding non functioning jts drive unit was reported.The event was confirmed by product inspection, during which the device was found damaged.The sales rep reported on the (b)(6) 2019 that the implant has not only failed to extend, but also reduced in height; however, he also reported on the (b)(6) 2020 that the patient was successfully extended of 6mm.

Event Description

It was reported the patient's jts distal femur implant underwent a series of very irregular lengthening events.

• Brand Name: JTS COIL
• 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: 9706423
• MDR Text Key: 189989520
• Report Number: 3004105610-2020-00028
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JTS-COIL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR