MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE FEMORAL SHAFT. L= 75MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number MSFSHFT-75

Device Problems Material Disintegration (1177); Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding metallosis/ abnormal ion levels involving a mets, distal femoral replacement, femoral shaft was reported.The event was not confirmed.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 mets distal femoral replacement, the date of insertion is unknown.The surgeon reported aseptic loosening of the implant and metallosis.The ct image provided shows radiolucency between the cement mantle and stem, and between the cement mantle and bone, along the femoral and tibial stems.The cement mantle was fragmented.There were gross bone resorption and remodelling, especially at femoral resection on the lateral side, which might be caused by metallosis.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate devices were manufactured and accepted into final stock 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 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 right distal femur with reason for surgery noted: "spindle cell sarcoma of bone." and reason for revision noted: "aseptic loosening and metallosis." during a case review meeting, it was confirmed that loosening and bone resorption is a consequence of the metallosis.Update 09jul2021: x ray review " products involved" update, as discussed with senior investigator and clinician the alleged metallosis is caused by metal devices in conjunction and/or relative motion so the following components should be investigated : stem ¿ shaft ¿ femoral component.

• Brand Name: FEMORAL SHAFT. L= 75MM
• 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
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12187298
• MDR Text Key: 262173418
• Report Number: 3004105610-2021-00112
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121029
• 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: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: MSFSHFT-75
• Device Lot Number: B7675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2010
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR