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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Insufficient Information (3190)
Patient Problems Injury (2348); Cancer (3262)
Event Date 02/03/2020
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
A patient specific implant prescription form was provided with diagnosis "leg length discrepancy" with notes "the remaining extension will be realized before the surgery.The overall replacement should consider the remaining extension.Tibial plateau plates." it has been further reported "the whole prosthesis is for revision".
 
Manufacturer Narrative
Reported event: an event regarding a limb length discrepancy involving a jts, distal extension mechanism was reported.The event was confirmed by x ray review.Method & results: device evaluation and results: not performed as no alleged device failure was reported.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for a jts distal femoral replacement which was inserted on the (b)(6) 2018.The surgeon reported leg length discrepancy.The ct scan provided showed that the affected femur is 33mm shorter than the opposite femur, which confirms the clinical report.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 02 may 2018 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 jts, distal femur, limb length discrepancy.There have been no other events.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, and return of the device are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
A patient specific implant prescription form was provided with diagnosis "leg length discrepancy" with notes "the remaining extension will be realized before the surgery.The overall replacement should consider the remaining extension.Tibial plateau plates." it has been further reported "the whole prosthesis is for revision".
 
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Brand Name
DISTAL FEMUR JTS
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 Key9779708
MDR Text Key183739005
Report Number3004105610-2020-00041
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K133152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 21333
Was Device Available for Evaluation? No
Date Manufacturer Received04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age14 YR
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