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

Catalog Number UNK_STM

Device Problem No Device Output (1435)

Patient Problems No Patient Involvement (2645); Cancer (3262)

Event Date 12/02/2019

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.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

As reported: "currently (jts drive unit) is lying at (b)(4).Based on last discussion with our marketing team and doctors, kit is malfunctioning and not operating properly." the device is being returned due to importation/ exportation regulations.

Manufacturer Narrative

Reported event: an event regarding alleged non functioning jts drive unit was reported.The event was not confirmed.Method and results: product evaluation and results: visual inspection.Pictures of the jts power unit and jts coil were taken.Visual inspection of the jts power unit reported minor scratches on the upper side.The jts coil does not show damage on the external surface.Functional inspection: jts drive unit has been functionally checked with the following problems.The casing to the electromagnet is opening up at the top showing its interior slightly.The serial number label to the electromagnet has its corners bent up and not adhered to the casing fully.Guides attached to electromagnet has several pages missing.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 inspection records (annual maintenance performed on (b)(6) 2019 indicates the device conformed to requirements.Complaint history review: based on the device identification the complaint databases were reviewed from 01jan2016 to present for similar reported events regarding non-functional jts drive unit.There have been 6 other events.Conclusions: the exact cause of the event could not be determined because further information such as functionality test is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as insufficient information was received by siw.If additional information become available to indicate further evaluation is warranted, this record will be re-opened.Siw will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

As reported: ".Currently (jts drive unit) is lying at(b)(4) mumbai.Based on last discussion with our marketing team and doctors, kit is malfunctioning and not operating properly." the device is being returned due to importation/ exportation regulations.Update 30jan2020 - dr reported the following "(jts drive unit) not expanding the implant in power mode 1.Expanded once in power band 3.Second attempt in power band 3 didnt work [.] (patient details) master (b)(6), distal femur osteosarcoma" (investigation under (b)(4)).

Event Description

As reported: ".Currently (jts drive unit) is lying at ftwz warehouse mumbai based on last discussion with our marketing team and doctors, kit is malfunctioning and not operating properly." the device is being returned due to importation/ exportation regulations.Update 30jan2020 - dr reported the following "(jts drive unit) not expanding the implant in power mode 1.Expanded once in power band 3.Second attempt in power band 3 didnt work [.] (patient details) master (b)(6), distal femur osteosarcoma" (investigation under (b)(4)).

Manufacturer Narrative

Reported event.An event regarding alleged non functioning jts drive unit was reported.The event was confirmed by itl report.Method and results.Product evaluation and results: visual inspection.Pictures of the jts power unit and jts coil were taken.Visual inspection of the jts power unit reported minor scratches on the upper side.The jts coil does not show damage on the external surface.Functional inspection.Jts drive unit has been functionally checked.With the following problems: ¿ the casing to the electromagnet is opening up at the top showing its interior slightly; ¿ the serial number label to the electromagnet has its corners bent up and not adhered to the casing fully; ¿ guides attached to electromagnet has several pages missing.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 inspection records (annual maintenance performed on (b)(6) 2019 indicates the device conformed to requirements.Complaint history review: based on the device identification the complaint databases were reviewed from 01jan2016 to present for similar reported events regarding non-functional jts drive unit.There have been 6 other events.Conclusions: the investigation concluded that the jts drive unit was faulty.For this reason, the unit was sent to itl for repair.The itl service report was provided on the 04sep2020, reporting the following: "investigation: unit has loose screws and screen had broken off [.] rectification: retightened some screws that was loose and replaced broken screen.Checked all other screws to make sure none were loose or broken inside the unit." no further investigation for this event is possible at this time as insufficient information was received by siw.If additional information become available to indicate further evaluation is warranted, this record will be re-opened.

• Brand Name: JTS DRIVE UNIT
• 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; UK WD6 3SJ
• MDR Report Key: 9488914
• MDR Text Key: 189991344
• Report Number: 3004105610-2019-00138
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2020

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: UNK_STM
• Device Lot Number: 907-117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 04/24/2020; 09/22/2020
• Supplement Dates FDA Received: 04/29/2020; 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other