MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG); PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Collapse (1099); Failure to Advance (2524)

Patient Problems Injury (2348); Cancer (3262)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Device not returned.

Event Description

A patient specific implant form was received with the diagnosis of revision for previous pin 17972 for the patient's distal femur minimally invasive grower."he has "concertinaed" down.He is at the point now where he cannot lengthen any more but has lost approximately 3.5cm in length".It has been further reported that "the locking screw was replaced with pin 20900 in (b)(6) 2017.The replacement screw cross threaded at the last lengthening which may have contributed to the femur collapsing".

Manufacturer Narrative

Reported event: an event regarding alleged collapsing involving a mig distal femoral replacement was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as no items were returned.Clinician review: the implant in situ was for a mig distal femoral replacement which was inserted on (b)(6) 2013 and the screw was changed on (b)(6) 2017.The clinician reported that the implant has been extended to its maximum (the implant was designed to have maximum extension of 85 mm) but collapsed afterward.As the result, the leg is shorter.The measurement x-ray provided showed that the implant is 35 mm extended and the affected leg is around 35 ¿ 40 mm shorter than the opposite leg, although the reason for the implant collapse cannot be assessed radiographically.Therefore, the x-ray review can confirm the clinical report.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 15jul2013 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01jan2017 to present for similar reported events regarding mig device's collapsing.There have been no other events.Conclusions: an event regarding alleged collapsing involving a mig distal femoral replacement was reported.The event was confirmed by medical review.The sales rep reported that the screw threaded during the last lengthening procedure and this could have caused the device to collapse.The exact cause of the event could not be determined because further information such as retrieval of the explanted device and 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/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.

Event Description

A patient specific implant form was received with the diagnosis of revision for previous pin 17972 for the patient's distal femur minimally invasive grower."he has concertinaed down.He is at the point now where he cannot lengthen any more but has lost approximately 3.5cm in length".It has been further reported that "the locking screw was replaced with pin 20900 on (b)(6) 2017.The replacement screw cross threaded at the last lengthening which may have contributed to the femur collapsing".

• Brand Name: DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG)
• 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: 9805900
• MDR Text Key: 183781148
• Report Number: 3004105610-2020-00052
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• 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: 04/16/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 17972
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 17 YR