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 Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Injury (2348); Cancer (3262)

Event Date 11/06/2019

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.Device not returned.

Event Description

A patient specific prescription form was submitted for patient's right total femur.Diagnosis is "failed modular total femoral rep".Note indicate "current implants are standard fixed hinge tibial component, custom distal femoral growing component with femoral stem cemented into construct proximally".Additional notes state "revision of all components planned.Patient currently has shortening ++ of right lower limb.Capacity to lengthen from current construct length by approx 1.5cm" the required by date is indicated as asap.Update (b)(6) 2019 - as reported by the sales rep, "patient didn¿t have anything revised on the (b)(6).(implant to be revised) due to a failed cement over mig over a hip stem.".

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.Reported event an event regarding failure of the cement mantle between a hip stem and a mig distal femur was reported.The event was confirmed by medical review.Method and results product evaluation and results: not performed as no items were received.Clinician review: the implant in situ was for a mig distal femoral replacement, in which the femoral tube cemented over the distal hip stem.The surgeon reported that this cement fixation has failed.The ct scan provided showed that the hip stem is tilted medially and misaligned with the mig component, which indicates that the hip stem is loose inside the femoral tube.However, the cement mantle inside the tube cannot be observed because of the metal work.Therefore, the radiographic assessment can confirm the reason for revision.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 10may2017 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01jan2016 to present for similar reported events regarding disassociation for cement failure involving mig distal femur.There have been no other events.Conclusions: an event regarding failure of the cement mantle between a hip stem and a mig distal femur was reported.The event was confirmed by medical review.The exact cause of the event could not be determined because further information such as retrieval analysis of the device, 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 prescription form was submitted for patient's right total femur.Diagnosis is "failed modular total femoral rep".Note indicate "current implants are standard fixed hinge tibial component, custom distal femoral growing component with femoral stem cemented into construct proximally".Additional notes state "revision of all components planned.Patient currently has shortening ++ of right lower limb.Capacity to lengthen from current construct length by approx 1.5cm" the required by date is indicated as asap.Update 14nov2019 - as reported by the sales rep, "patient didn¿t have anything revised on the 6th [.] (implant to be revised) due to a failed cement over mig over a hip stem".

• 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: 9400763
• MDR Text Key: 168870492
• Report Number: 3004105610-2019-00126
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 19997
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR