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

Catalog Number MSFSHFT-75

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Cancer (3262)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding limb length discrepancy involving a mets total femur was reported.The event was not confirmed.Method and results: product evaluation and results: nor performed as no items were returned.Clinician review: the implant in situ was for a mets total femoral replacement.The surgeon reported a leg length discrepancy following a fracture.The x ray provided shows the total femoral implant is intact and there is no fracture being observed.Also, there is no imaging provided for the opposite leg, therefore the leg length discrepancy cannot be assessed.In conclusion the above radiographic assessment cannot confirm the reason for revision.Product history review: review of the product history records indicate 19 devices were manufactured and accepted into final stock on (b)(6) with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed for similar events regarding limb length discrepancy lot b15817 there have been no other events for the lot referenced.Conclusions: an event regarding limb length discrepancy involving a mets total femur was reported, due to previous cases of fracture (investigated in siw-16-1515).A revision implant (pin 22113) was requested; the revision surgery has not been scheduled yet.The exact cause of the event could not be determined because further information such as complete x-rays and 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.Catalog numbers and lot codes of other devices listed in this report: mkfe-lsm (a16081) femoral knee, mstfl-165 (b13679) total femoral link shaft, mstrc-lsmlu (b15370) trochanter, msfmh-cc28m0 (b14663) femoral head.Device not returned.

Event Description

A patient specific prescription form was submitted for patient's left total femur.Diagnosis is "lld following fracture".Note indicates "silver coated [blank] epr 9cm lld following number and revision ".Update (b)(6) 2019: as reported in the x-ray review, the implant in situ was a mets total femur.

• 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; GB WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 9400704
• MDR Text Key: 168836097
• Report Number: 3004105610-2019-00125
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K121055
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: MSFSHFT-75
• Device Lot Number: B15817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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: 22 YR