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

Catalog Number UNK_STM

Device Problem Fracture (1260)

Patient Problems Injury (2348); Cancer (3262)

Event Date 03/09/2020

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

A patient specific implant prescription form was received for the patient's right distal femur with diagnosis: osteosarcoma.Notes indicate type 3 distal femoral endoprosthesis now fractured.Need revision of distal femur endoprosthesis asap please.Additional notes: revision type 3 distal femur endoprosthesis to replace broken component and retain existing tibial component.Surgeon confirmed that the patient's stem has broken.

Event Description

A patient specific implant prescription form was received for the patient's right distal femur with diagnosis: osteosarcoma.Notes indicate type 3 distal femoral endoprosthesis now fractured.Need revision of distal femur endoprosthesis asap please.Additional notes: revision type 3 distal femur endoprosthesis to replace broken component and retain existing tibial component.Surgeon confirmed that the patient's stem has broken.

Manufacturer Narrative

Reported event: an event regarding crack/ fracture involving a patient specific distal femur was reported.The event was confirmed by x-ray review.Method & results: device evaluation and results: not performed as product was not returned clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for a distal femoral replacement which was inserted on (b)(6) 1993.Surgeon reported that the implant has fractured.The x-rays provided showed that the distal femoral implant has fractured at the junction between stem and shaft which confirms the reason for revision.Device history review: review of the product history records indicate (b)(4) device was manufactured and accepted into final stock on 09jul1993 with no reported discrepancies.Complaint history review: there have been no 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, 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.

• Brand Name: DISTAL FEMUR
• 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: 9928321
• MDR Text Key: 188058394
• Report Number: 3004105610-2020-00078
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K140898
• 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: 07/02/2020

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 Catalogue Number: UNK_STM
• Device Lot Number: PIN 2783
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 06/08/2020
• Supplement Dates FDA Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR