MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR MIG; LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problem Material Separation (1562)

Patient Problems Failure of Implant (1924); Cancer (3262)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device remains implanted.

Event Description

Message received from surgeon provides 2 x-ray images and reports ".Put in 2014.The axle is visible on the medial aspect of the femoral component, like if the axle is backing up.This picture is completely unchanged from 2014 to 2018.She has no symptoms".Associate manager of product development reported "it's clear in both images that the axle is not in the correct position.An axle cap is used to restrict the axle from backing out of the hinged knee components.The axle needs pressing back into the correct position and an axle cap needs reinserting".

Event Description

Message received from surgeon provides 2 x-ray images and reports " put in (b)(6).The axle is visible on the medial aspect of the femoral component, like if the axle is backing up.This picture is completely unchanged from (b)(6) to (b)(6).She has no symptoms".Associate manager of product development reported "it's clear in both images that the axle is not in the correct position.An axle cap is used to restrict the axle from backing out of the hinged knee components.The axle needs pressing back into the correct position and an axle cap needs reinserting".

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.Corrected data - implant date from (b)(6) 2014 to (b)(6) 2013.An event regarding alleged axle backing out involving a mig distal femur was reported.This 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 mig distal femoral replacement, which was inserted on (b)(6) 2013.The surgeon reported the axel became visible on the medial side.The x-ray provided showed the axel has backed out on both the medial and lateral sides, but the axle cap cannot be seen on x-ray.This confirms the reason for revision.Product history review: review of the product history records indicate (b)(4) device was manufactured and accepted into final stock on 28mar2013 with no reported discrepancies.Complaint history review: there has been 1 other event relevant to this investigation.Conclusions: 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 insufficient information was received by siw.If devices and additional information become available to indicate further evaluation is warranted, this record will be re-opened.Siw will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.Device not returned.

• Brand Name: DISTAL FEMUR MIG
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• MDR Report Key: 8184312
• MDR Text Key: 131002062
• Report Number: 3004105610-2018-00157
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• 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: 04/30/2019

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: Lay User/Patient
• Device Catalogue Number: UNK_STM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMBPR00(B10531) BUMPER PAD; SMBSH00(B10530)BUSHES; SMCAP01(B10529)AXLE CAP
• Patient Outcome(s): Other
• Patient Age: 12 YR