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

Catalog Number UNK_STM

Device Problems Positioning Problem (3009); Insufficient Information (3190)

Patient Problem Cancer (3262)

Event Date 08/14/2019

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.Device not returned.

Event Description

It was reported "the surgeon struggled to screw in the screw for the distal part of the implant.Alignment was the issue." there was a 1 hour delay.

Event Description

It was reported "the surgeon struggled to screw in the screw for the distal part of the implant.Alignment was the issue.".

Manufacturer Narrative

An event regarding assembly issue during surgery involving a screw for a jts midshaft femur was reported.The event was confirmed by stryker engineers attending the surgery.Method and results product evaluation and results: not performed as device is implanted.Clinician review: not performed as no medical records were provided.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 08aug2019 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 14-aug-2016 to present for similar reported events regarding an assembly issue involving a screw.There have been no other events.Conclusions: an event regarding assembly issue during surgery involving a screw for a jts midshaft femur was reported.It was reported by the sales rep that the surgeon had difficulties in inserting the screw for the distal part of the implant, causing 1 hour delay.The surgeon burred around the pilot hole and the screw engaged.The screw was inserted successfully and the distal portion was bolted onto the rest of the diaphyseal implant.As per discussion with the production development engineer, it was reported that this case was complex due to the complex design features of the device.Moreover, it was also reported that the surgeon experienced issues during the alignment of the distal part of the device due to the body forces acting on the implant; he solved this issue by enlarging the hole for the screw.The subject matter expert principal engineer product development reviewed the event and stated: "during surgery the prosthesis, which was supplied assembled, was disassembled to insert as per operation plan.During the reassembly, aligning the prosthesis to allow the bolts to secure the detachable stem to the shaft was difficult.The surgeon opened up the unthreaded hole on the shaft portion using a burr, which facilitated the alignment of this hole with the threaded hole in the stem and the bolt was used to secure and complete the assembly as per operation plan." the exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary operative report as well 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/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.

• Brand Name: JTS FEMORAL DIAPHYSEAL REPLACEMENT
• 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: 8991781
• MDR Text Key: 189990847
• Report Number: 3004105610-2019-00101
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• 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: PIN 21835
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR