MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE ALIGNMENT GUIDE; 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.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" 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" 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 an alignment tool was reported.The event was confirmed by photographs.Method and results: product evaluation and results: pictures sent by the surgeon showed that the square peg on the top of the alignment tool is damaged.Clinician review: not performed as no medical record was received.Product history review: review of the product history records indicate (b)(4) was manufactured and accepted into final stock on 03mar2020 with no reported discrepancies.Complaint history review: there have been no other events.Conclusions: an event regarding disassembly issue involving an alignment tool was reported.The event was confirmed by photographs.The senior staff design engineer reviewed the event and explained that, in order to remove the lead screw, it is possible to use the alignment tool provided, whose main function is however to align the new leadscrew with the piston.The resistance may have been caused by the jts not being extended for a long time, but this needs to be confirmed by the surgeon.As reported the surgeon wanted not to further extend the device and to revise it since close to max extension.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 because further information such as analysis on the returned product is 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: ALIGNMENT GUIDE
• 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: 9989886
• MDR Text Key: 214824939
• Report Number: 3004105610-2020-00086
• 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 22249
• Was Device Available for Evaluation?: No
• 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