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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 Unintended Movement (3026)
Patient Problems Fall (1848); Cancer (3262)
Event Date 04/15/2020
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
As reported by surgeon: "this patient of mine with a long distal femur noticed an abrupt change in rotation of her leg.There was no antecedent trauma.She has had a couple of falls but x-rays following that looked unchanged.A powerpoint was put together with x-rays and fluoro images we took yesterday under anesthesia.I will also send a clinical video i took on my phone.We will be sending her cd with the images to you today.Need help in sorting out what has changed with her implant." a powerpoint with imaging adds "mid-april: she was in bed, reached behind her back to move a pillow, when she moved the leg and felt a painless pop.She immediately noticed that her leg was more externally rotated.".
 
Manufacturer Narrative
Reported event: an event regarding disassociation (and consequent rotation) involving a jts distal femur was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed since no items were returned.Clinician review: the implant in situ was for a jts distal femoral replacement which was inserted in (b)(6) 2019.The surgeon reported that the patient had an abrupt change in rotation of the knee joint without obvious trauma for this incidence but has several falls in the past.The x-rays provided showed that the femoral component has externally rotated but the femoral and tibial components are engaged.The newly supplied ct scan suggested that the shrink fit between the inner piston and the collar device might fail, which is evidenced by the rotated position of the keyway which is supposed to be on the front.However, this possible failure mode needs to be confirmed by the retrieved implant.The above radiographic observation can confirm the clinical report.Product history review: review of the product history records indicate 1 was manufactured and accepted into final stock on 16oct2019 with no reported discrepancies.Complaint history review: there has been 1 other event.Conclusions: an event regarding disassociation (and consequent rotation) involving a jts distal femur was reported.The event was confirmed by medical review.The exact cause of the event could not be determined because further information such as retrieval analysis 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.
 
Event Description
As reported by surgeon: "this patient of mine with a long distal femur noticed an abrupt change in rotation of her leg.There was no antecedent trauma.She has had a couple of falls but x-rays following that looked unchanged.A powerpoint was put together with x-rays and fluoro images we took yesterday under anesthesia.I will also send a clinical video i took on my phone.We will be sending her cd with the images to you today.Need help in sorting out what has changed with her implant." a powerpoint with imaging adds "mid-april: she was in bed, reached behind her back to move a pillow, when she moved the leg and felt a painless pop.She immediately noticed that her leg was more externally rotated.".
 
Manufacturer Narrative
Reported event: an event regarding disassociation (and consequent rotation) involving a jts distal femur was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed since no items were returned.Clinician review: the implant in situ was for a jts distal femoral replacement which was inserted on (b)(6) 2019.The surgeon reported that the patient had an abrupt change in rotation of the knee joint without obvious trauma for this incidence but has several falls in the past.The x-rays provided showed that the femoral component has externally rotated but the femoral and tibial components are engaged.The newly supplied ct scan suggested that the shrink fit between the inner piston and the collar device might fail, which is evidenced by the rotated position of the keyway which suppose to be on the front.However, this possible failure mode needs to be confirmed by the retrieved implant.The above radiographic observation can confirm the clinical report.Update 23oct2020 - additional medical records were provided and it was possible to confirm that: the shrink fit between the inner piston and the collar failed; the solution provided with pin 22457 ¿ option 3 solved the issue initially reported.Product history review: review of the product history records indicate 1 was manufactured and accepted into final stock on (b)(6) 2019 with no reported discrepancies.Complaint history review: there has been 1 other event.Conclusions: an event regarding disassociation (and consequent rotation) involving a jts distal femur was reported.The event was confirmed by medical review.The exact cause of the event could not be determined because further information such as retrieval analysis 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.Siw will continue to monitor for trends.
 
Event Description
As reported by surgeon: "this patient of mine with a long distal femur noticed an abrupt change in rotation of her leg.There was no antecedent trauma.She has had a couple of falls but x-rays following that looked unchanged.A powerpoint was put together with x-rays and fluoro images we took yesterday under anesthesia.I will also send a clinical video i took on my phone.We will be sending her cd with the images to you today.Need help in sorting out what has changed with her implant." a powerpoint with imaging adds "(b)(6): she was in bed, reached behind her back to move a pillow, when she moved the leg and felt a painless pop.She immediately noticed that her leg was more externally rotated." update 23oct2020 - as per sales rep email "this revision surgery took place on monday and everything went successfully.I am attaching photos.We did not explant anything and we tested the implant with the mle after the clip was in place.There are several videos before the clip and after".
 
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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
UK  WD6 3SJ
MDR Report Key10153283
MDR Text Key195393090
Report Number3004105610-2020-00104
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
Type of Report Initial,Followup,Followup
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 22097
Was Device Available for Evaluation? No
Date Manufacturer Received11/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age11 YR
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