MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMORAL REPLACEMENT - FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646); Cancer (3262)

Event Date 02/27/2020

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.Not returned.

Event Description

A patient specific implant form was received for the patient's left distal femur with the following information: reason for revision: aseptic loosening, femoral prosthesis.

Manufacturer Narrative

Reported event: an event regarding alleged aseptic loosening involving a femoral stem of a patient specific 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 distal femoral replacement which was inserted on (b)(6) 2016.The surgeon reported that the stem has aseptically loosened.The x-ray provided shows massive radiolucent line along the femoral mainly between the cement mantle and bone, and there is osteolytic lesion at the tip of the femoral stem.There is also massive radiolucent line along the tibial stem between the cement and stem and between the cement and bone.There is significant bone resorption and lesion on the tibial cortical bone.The above x-ray review 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 21jan2016 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 loosening of femoral stem involving patient specific distal femur.There have been 5 other events.Conclusions: an event regarding alleged aseptic loosening involving a femoral stem of a patient specific distal femoral replacement was reported.The event was confirmed by medical review.The exact cause of the event could not be determined because further information such as 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 for the patient's left distal femur with the following information: reason for revision: aseptic loosening, femoral prosthesis.Update 26mar2020 - loosening of both the femoral and tibial stems was identified.

• Brand Name: DISTAL FEMORAL REPLACEMENT - FEMORAL STEM
• 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: 9876633
• MDR Text Key: 188058685
• Report Number: 3004105610-2020-00070
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• 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: PIN19099
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR