MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE REBUSHING REVISION - AXLE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Material Erosion (1214)

Patient Problems Injury (2348); Cancer (3262)

Event Date 02/05/2020

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

Revision of a (b)(6) yr old stanmore dfr.Revision for routine wear and tear, surgeon is not concerned at all, and recognises this not an unexpected product failure.

Manufacturer Narrative

Reported event: an event regarding wear involving 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) 1993 initially, and partially revised in 2011.The surgeon reported normal wear and tear and asked for a rebushing.The x-ray provided showed that the femoral component is engaged with the tibial component and the axle is in place.Both the femoral and tibial stems are well fixed.It is hard to assess the wear and tear from the radiographic images, but this would be expected to happen after an implant in situ for 27 years.Therefore, the above radiographic assessment can support the clinical report.Product history review: review of the product history records indicate 1 devices was manufactured and accepted into final stock on 12aug2011 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 wear of axle components in patient specific distal femoral replacements.There have been no other events.Conclusions: an event regarding wear involving a patient specific distal femoral replacement was reported.The event was confirmed by medical review.The implant remained in situ for 27 years and a revision for wear is a common practice after such a long time, as confirmed in the xray 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

Revision of a 31 yr old stanmore dfr.Revision for routine wear and tear, surgeon is not concerned at all, and recognises this not an unexpected product failure.

• Brand Name: REBUSHING REVISION - AXLE
• 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: 9817804
• MDR Text Key: 183783424
• Report Number: 3004105610-2020-00060
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• 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: PIN 16490
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR