MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE JTS DISTAL FEMUR - LEAD SCREW; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Insufficient Information (3190); Difficult or Delayed Separation (4044)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/25/2020

Event Type  malfunction  

Manufacturer Narrative

The following devices were also listed in this report: jts distal femur - distal component; pin 19569.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.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

During a revision of the patient's right distal femur (stryker ref 20192267738, fda ref 3004105610-2019-00141 sent 20dec2019), the surgeon reported the following: "first problem: after the smiles knee was disassembled, it was not so easy to slide out the distal femoral component in situ.It was necessary to use a hammer to give a little shock to slide it out.It is only a little problem"."second problem: the leadscrew was blocked into the piston in-situ.I have used the alignment tool as recommended by you.But i tried to unscrew the leadscrew with the alignment tool, but the square peg on the top of the alignment tool twisted.It was finally possible to unscrew the leadscrew by using a self-grip pliers.I replaced it by the new lead screw and it was easy to screw the new lead screw without forcing.But as the square peg was twisted, it was not so easy to align the two components, but i finally succeeded to do it.As the leadscrew was difficult to extract, there was a surgical delay of around 10 to 15 minutes.".

Event Description

During a revision of the patient's right distal femur (stryker ref (b)(4), fda ref 3004105610-2019-00141 sent 20dec2019), the surgeon reported the following: "first problem : after the smiles knee was disassembled, it was not so easy to slide out the distal femoral component in situ.It was necessary to use a hammer to give a little shock to slide it out.It is only a little problem"."second problem : the leadscrew was blocked into the piston in-situ.I have used the alignment tool as recommended by you.But i tried to unscrew the leadscrew with the alignment tool, but the square peg on the top of the alignment tool twisted.It was finally possible to unscrew the leadscrew by using a self-grip pliers.I replaced it by the new lead screw and it was easy to screw the new lead screw without forcing.But as the square peg was twisted, it was not so easy to align the two components, but i finally succeeded to do it.As the leadscrew was difficult to extract, there was a surgical delay of around 10 to 15 minutes".

Manufacturer Narrative

Reported event: an event regarding disassembly issue involving a lead screw from jts distal femur was reported.The event was not confirmed.Method and results: product evaluation and results: visual inspection - lead screw (pin 19569) was received together with instruments for the revision case pin 22249.Visual inspection of the returned component did not identify any damage or non-conformity relevant to the reported event.This was also confirmed by quality inspection.Dimensional inspection - the device is dimensionally within specification.Clinician review: not performed as no medical record was received.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 12aug2015 with no reported discrepancies.Complaint history review: there have been no other events.Conclusions: an event regarding disassembly issue involving a lead screw from jts distal femur was reported.The event was not confirmed.The senior staff design engineer reviewed the event and explained that it is possible to find a bit of resistance in removing the distal part, since the lead screw at this point is still engaged.The surgeon also reported that the surgery was successfully concluded with 10-15 mins delay.The exact cause of the event could not be determined since no evident damage was found on the returned product that could have explained the origin of the issue.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.Siw will continue to monitor for trends.

• Brand Name: JTS DISTAL FEMUR - LEAD SCREW
• 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: 9989759
• MDR Text Key: 214825081
• Report Number: 3004105610-2020-00085
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

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: PIN 19569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 11 YR
• Patient Weight: 47