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

Catalog Number UNK_STM

Device Problems Fracture (1260); Loss of Osseointegration (2408)

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

Event Date 01/29/2020

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

The sales rep reported a suspected failure of an implant.The device is scheduled to be revised (b)(6) 2020."we think that it was a loosening of the stem distally that caused the stem to toggle and fracture.Patient is a builder and has normal activity levels.".

Manufacturer Narrative

Reported event: an event regarding a fracture due to loosening, involving a patient specific, distal femur was reported.The fracture was confirmed by visual inspection.Method & results: visual inspection: visual inspection of the photographed distal femur displays a fracture at the cemented femoral stem.The fracture is located at the lower third of the stem closest to the ha collar.The fracture line is quite straight, and the fracture groove imaged above is fairly level.Dimensional inspection: not performed as no items were returned.Functional inspection: not performed as no items were returned.Material analysis: not performed as no items were returned.Clinician review: no medical records or x ray images 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) 2008 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01-jan-2017 to present for similar reported events regarding, patient specific, distal femur, femoral stem, loosening.There have been 8 other events.Conclusion: it was reported by the sales rep that a fracture due to loosening was reported.However, the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology, 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

The sales rep reported a suspected failure of an implant.The device is scheduled to be revised (b)(6) 2020."we think that it was a loosening of the stem distally that caused the stem to toggle and fracture.Patient is a builder and has normal activity levels.".

• 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: 9756674
• MDR Text Key: 183737469
• Report Number: 3004105610-2020-00039
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

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 13840
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR