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

Catalog Number UNK_STM

Device Problems Loss of Osseointegration (2408); Malposition of Device (2616)

Patient Problem Inadequate Osseointegration (2646)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

A patient specific prescription form was received for the patient's left distal femur with reason for revision noted: reason for surgery: "osteosarcoma / loose stem" with reason for revision being: "the expansion is complete.".

Manufacturer Narrative

Additional manufacturer narrative reported event: an event regarding loosening involving a jts, distal femur, femoral stem 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 jts distal femoral replacement which was inserted in 2015.The surgeon reported maximum extension and loosening of the stem.The ct image provided shows the radiolucent line between the cement mantle and femoral bone; the femoral stem was mal-aligned with the proximal femur in which the proximal femoral bone has moved in varus position.This is probably due to the loosening of the stem.The implant has been extended by 50 mm which has almost reached to its maximum capacity of 60 mm.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 11 dec 2015 with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.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

A patient specific prescription form was received for the patient's left distal femur with reason for revision noted: reason for surgery: "osteosarcoma / loose stem" with reason for revision being: "the expansion is complete.".

• 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; UK WD6 3SJ
• MDR Report Key: 10665547
• MDR Text Key: 211024538
• Report Number: 3004105610-2020-00161
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 19846
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 11 YR