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

Model Number PIN 12560

Device Problem Device-Device Incompatibility (2919)

Patient Problems Injury (2348); Cancer (3262)

Event Date 04/03/2019

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.

Event Description

At approximately 15:10, on (b)(6) 2019, it was reported by (b)(6) by a phone call to the siw design office, that the surgeon mr (b)(6) was having difficulty inserting the jts revision prosthesis (pin21882).Mr (b)(6) requested the attendance of a design engineer in surgery to troubleshoot why the device was not fitting as intended.(b)(6) went to theatres in (b)(6) as requested and (b)(6) entered theatre 7.The device was confirmed to not fit as intended.The surgeon reinserted the original proximal component and scribed a line on the end of the shaft to annotate the femoral neck angle.He removed this component and inserted the revision component and scribed the neck angle.The discrepancy between the two scribed lines was approximately 90 degrees.On discussion, the surgeon decided to leave the distal femoral component of the jts in situ as the patient still had a leg length discrepancy.On further discussion, the surgeon decided to retain the original proximal component as a spacer scaffold onto which a mets trochanter was cemented allowing the surgeon to close the patient with a view to revising at a later date.The pin numbers being revised were bme(pin)12560 and bme(pin)13138.There was a surgical delay of 30-60 minutes.

Manufacturer Narrative

Reported event: an event regarding an alleged assembly issue involving a jts proximal femoral replacement revision device that was intended to align with an in situ midshaft femur jts was reported.The event was confirmed by siw design engineers in attendance at the procedure.Method and results: product evaluation and results: visual inspection: the returned device has minor visible discoloration and surface marks that are unrelated to the reported event.Assessment of the returned device indicates that the keyway groove is positioned anteriorly.The returned device is otherwise visually unremarkable.Dimensional inspection not performed as reported issue is not dimensional.Functional inspection not performed as reported issues is not functional.Material analysis not performed as the reported issue is not material.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicate one device was manufactured and accepted into final stock on 28mar2019 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01apr2016 to present for similar reported events regarding revision assembly/fit and alignment issues there have been no other events.An nc was issued to complete a full investigation and determine root cause and corrective action.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Siw will continue to monitor for trends.In april 2019, stanmore implants worldwide initiated a field safety corrective action in the uk on mhra ref: 2019/004/012/291/007 stanmore reference # 2053165.Future remittance of information will be done through the fsca.

Event Description

At approximately 15:10, on (b)(6) 2019, it was reported by bb by a phone call to the siw design office, that the surgeon mr rp was having difficulty inserting the jts revision prosthesis (pin21882).Mr rp requested the attendance of a design engineer in surgery to troubleshoot why the device was not fitting as intended.Ms, kw and gb went to theatres in the rnoh as requested and ms entered (b)(6).The device was confirmed to not fit as intended.The surgeon reinserted the original proximal component and scribed a line on the end of the shaft to annotate the femoral neck angle.He removed this component and inserted the revision component and scribed the neck angle.The discrepancy between the two scribed lines was approximately 90 degrees.On discussion, the surgeon decided to leave the distal femoral component of the jts in situ as the patient still had a leg length discrepancy.On further discussion, the surgeon decided to retain the original proximal component as a spacer scaffold onto which a mets trochanter was cemented allowing the surgeon to close the patient with a view to revising at a later date.The pin numbers being revised were bme(pin)12560 and bme(pin)13138.There was a surgical delay of 30-60 minutes.

• Brand Name: JTS MIDSHAFT FEMUR REPLACEMENT
• 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: 8499890
• MDR Text Key: 141479283
• Report Number: 3004105610-2019-00045
• 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: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PIN 12560
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 12560
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PIN 13138 REVISION EXTENSION SHAFT JTS MIDSHAFT; PIN 21882 JTS PROXIMAL FEMUR REPLACEMENT; REV EXT SHAFT FOR JTS MIDSHAFT FEMUR PIN13138; PIN 13138 REVISION EXTENSION SHAFT JTS MIDSHAFT; PIN 21882 JTS PROXIMAL FEMUR REPLACEMENT
• Patient Outcome(s): Hospitalization
• Patient Age: 39 YR