MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE JTS DISTAL FEMUR; LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problems Activation Problem (4042); Unclear Information (4052)

Patient Problem Injury (2348)

Event Date 06/13/2018

Event Type  Injury  

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 upon completion of the investigation.Device not returned.

Event Description

It was reported that on the (b)(6) 2018 when there was an attempt to lengthen, which was unsuccessful.Difficulty lengthening.

Manufacturer Narrative

An event regarding alleged failure to extend involving a jts distal femur was reported.The event was confirmed by medical review.The reported event regarding alleged failure to extend involving a jts distal femur is further reported to be related to patient factors.The device remains in situ and there is currently no intention to revise the device.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 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.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

It was reported that on the (b)(6) 2018 when there was an attempt to lengthen, which was unsuccessful.Difficulty lengthening.

• Brand Name: JTS DISTAL FEMUR
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• MDR Report Key: 7680982
• MDR Text Key: 113743923
• Report Number: 3004105610-2018-00058
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K092138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 20574
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR