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

Catalog Number UNK_STM

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348); Cancer (3262)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

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

As reported by customer service support: "the patient¿s mother has contacted me today to say that the patient fell off a hoverboard on friday and is currently in hospital after part of the implant broke- this relates to a screw.This is all the information i have at the moment.".

Manufacturer Narrative

Reported event: an event regarding crack/ fracture involving a jts, distal femur, femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device remains implanted.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on (b)(6) 2019 with no reported discrepancies.Complaint history review: there has been 3 other events.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

As reported by customer service support: "the patient¿s mother has contacted me today to say that the patient fell off a hoverboard on friday and is currently in hospital after part of the implant broke: this relates to a screw.This is all the information i have at the moment." update (b)(6) 2020: the neck of the femur has fractured, not the implant.The surgeon operated on the patient on the (b)(6) 2020, using 2 screw's proximal to the implant to fix the fracture.

• Brand Name: DISTAL FEMUR JTS
• 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: 10139476
• MDR Text Key: 194681665
• Report Number: 3004105610-2020-00102
• 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: 09/02/2020

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 Expiration Date: 12/31/2019
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 21969
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR