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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 Problems Use of Device Problem (1670); Failure to Advance (2524); Mechanical Jam (2983)
Patient Problems No Known Impact Or Consequence To Patient (2692); Cancer (3262)
Event Date 11/04/2019
Event Type  malfunction  
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.Device not returned.
 
Event Description
It is reported " first attempt has been performed with no success last 25 of august with power unit set on 0.Second attempt today.Additional notes state "center is exposed to jts system, never got problems before.Same skilled physician as in the past.It has been tried several time the unlocking procedure to switch from b to a.Power unit set on 3 and 4.Implant sounded as locked, sounded working going reverse (b) and then going ahead (a) but just for a few seconds.".
 
Event Description
It is reported " first attempt has been performed with no success last 25 of august with power unit set on 0.Second attempt today.Additional notes state "center is exposed to jts system, never got problems before.Same skilled physician as in the past.It has been tried several time the unlocking procedure to switch from b to a.Power unit set on 3 and 4.Implant sounded as locked, sounded working going reverse (b) and then going ahead (a) but just for a few seconds.".
 
Manufacturer Narrative
An event regarding seizing involving a jts distal femur, extension mechanism was reported.The event was confirmed by x ray review.Method & results: -device evaluation and results: not performed as product remains implanted.-clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ is a jts distal femoral replacement which was inserted on the (b)(6) 2018.The surgeon reported that the implant has ceased to extend after several successful extensions.The imaging provided showed that the implant is well fixed inside the cavity and has been extended around 20mm out of the maximum capacity of 50mm.The affected leg is slightly shorter than the opposite leg, which 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 (b)(6) 2018 with no reported discrepancies -complaint history review: based on the device identification the complaint databases were reviewed from 01jan2017 for similar reported events regarding jts distal femur seizing.There have been 9 other events.-conclusion an event regarding seizing involving a jts, distal femur, extension mechanism was reported.No further investigation for this event is possible at this time as no devices or additional information was received.If the device or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Manufacturer Narrative
An event regarding seizing involving a jts, distal femur, extension mechanism was reported.The event was confirmed by x ray review.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ is a jts distal femoral replacement which was inserted on the (b)(6) 2018.The surgeon reported that the implant has ceased to extend after several successful extensions.The imaging provided showed that the implant is well fixed inside the cavity and has been extended around 20mm out of the maximum capacity of 50mm.The affected leg is slightly shorter than the opposite leg, which 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 (b)(6) 2018 with no reported discrepancies complaint history review: there have been 9 other events.Conclusion an event regarding seizing involving a jts, distal femur, extension mechanism was reported.No further investigation for this event is possible at this time as no devices or additional information was received.If the device or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Update: further information was received by the sales rep on (b)(6) 2020, the implant in situ has now been successfully extended.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 or the product is returned, this investigation will be re-opened.
 
Event Description
It is reported " first attempt has been performed with no success last (b)(6) with power unit set on 0.Second attempt today.Additional notes state "center is exposed to jts system, never got problems before.Same skilled physician as in the past.It has been tried several time the unlocking procedure to switch from b to a.Power unit set on 3 and 4.Implant sounded as locked, sounded working going reverse (b) and then going ahead (a) but just for a few seconds." update (b)(6) 2020: the rep reported ,"the implant of the patient has now been successfully extended".
 
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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 Key9390168
MDR Text Key189990722
Report Number3004105610-2019-00123
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,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2018
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 21078
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/04/2019
Initial Date FDA Received11/28/2019
Supplement Dates Manufacturer Received03/13/2020
08/05/2020
Supplement Dates FDA Received03/18/2020
09/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age14 YR
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