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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE TOTAL FEMUR JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STANMORE IMPLANTS WORLDWIDE TOTAL FEMUR JTS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Insufficient Information (3190)
Patient Problems Muscular Rigidity (1968); Pain (1994); Injury (2348); Cancer (3262)
Event Date 02/26/2020
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.Not returned.
 
Event Description
A patient specific prescription form was received for the patient's left total femur with the following information: reason for revision: limb length discrepancy.Notes: overall replacement - 325mm.Max extension - 110mm.Tibial augmentation (cone) 30 mm.Additional information provided by the rep: "the patient has a muscle contracture of flexion-extension by 45 degrees and limb shortening by 50-80 mm.The surgeon wishes to revise the whole implant and add a tibial conus augment.".
 
Manufacturer Narrative
Reported event: an event regarding limb length discrepancy involving a jts, total femur, extension mechanism was reported.The event was confirmed by x ray review.Method & results: device evaluation and results: not performed as product was not returned clinician review: the implant in situ was for a jts total femoral replacement which was inserted in 2017.The surgeon reported that the patient had muscle contracture and the knee joint was in flexion.The ct scan provided showed that the femoral component is aligned and engaged with the tibial component, but the knee is in flexion which might indicate that the knee joint cannot be straightened which may be due to muscle contracture.In addition, measuring from the ct scan showed that the affect femur is over 30 mm shorter than the opposite femur.Therefore, the radiographic review can confirm the clinical report.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 06 feb 2017 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 a jts, total femur, extension mechanism, 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, pathology reports, progress notes, 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.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.
 
Event Description
A patient specific prescription form was received for the patient's left total femur with the following information: reason for revision: limb length discrepancy.Notes: overall replacement - 325mm.Max extension - 110mm.Tibial augmentation (cone) 30 mm.Additional information provided by the rep: "the patient has a muscle contracture of flexion-extension by 45 degrees and limb shortening by 50-80 mm.The surgeon wishes to revise the whole implant and add a tibial conus augment.".
 
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Brand Name
TOTAL 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 Key9877374
MDR Text Key188058767
Report Number3004105610-2020-00072
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K092138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2017
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 20494
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age12 YR
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