MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR MIG; LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problem Material Separation (1562)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

An event regarding an alleged broken prosthesis involving a distal femur mig was reported.The event was not confirmed however, it has been observed that the retaining ring for the worm screw has disassociated, this may have caused the surgeon to believe this is fractured.Method and results not performed as no items were returned.Medical records received and evaluation: x-ray review - based on a review of the provided information, the reported fracture of the prosthesis cannot be confirmed.However, it has been observed that the retaining ring for the worm screw has disassociated, this may have caused the surgeon to believe this is fractured.Radiolucent lines around the tibial component have been observed.No design or manufacturing related issues have been identified.Product history review: review of the device history record indicate one device was manufactured and accepted into final stock on 29 jun 2000, with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 2012 to present for similar reported events regarding disassociation of retaining ring for worm screw.There have been no other events.Conclusions: the exact cause of the event could not be determined because further information such as device return, 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 insufficient information was received by siw.If devices and additional information become available to indicate further evaluation is warranted, this record will be re-opened.Siw will continue to monitor for trends.It is confirmed that a revision procedure was successfully completed with no reported complications.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product nonconformity or unanticipated hazard.Please note: the reported device is similar to a distal femur mig device approved for compassionate use in the united states.Device not available.

Event Description

It has been reported that the patient requires a revision due to fracture of the prosthesis.The surgeon intends to revise the femur and tibia.

• Brand Name: DISTAL FEMUR MIG
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer Contact: margaret foley ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 8079116
• MDR Text Key: 127408881
• Report Number: 3004105610-2018-00142
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2000
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 7541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2000
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DISTAL FEMUR MIG PIN 3233; DISTAL FEMUR MIG TIBIAL COMPONENTS PIN 9015
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR