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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number PIN 18932
Device Problem Fracture (1260)
Patient Problems Injury (2348); Inadequate Osseointegration (2646); Cancer (3262)
Event Date 05/26/2020
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.Device not returned.
 
Event Description
As reported in a text message received by regional oncology specialist by surgeon: "this patient who had a stanmore put in.In 2014.He has reached maximal expansion and unfortunately this happened over the weekend (x-ray images show a broken femoral stem).Going to revise this to a stryker adult hopefully tomorrow ((b)(6) 2020).
 
Manufacturer Narrative
Reported event: an event regarding fracture of a femoral stem in a jts distal femur was reported.The event was confirmed by medical review.Method and results product evaluation and results: visual inspection intraoperative pictures of jts distal femur pin 18932 were received, showing the device in situ and subsequently explanted.In the picture showing the device still in situ, it is possible to notice mainly the shaft and part of the femoral component and the collar.Visual inspection of the picture showing the explanted device confirmed that the femoral stem fractured.No damage or non-conformity relevant to the reported event was identified in all the other components.Clinician review: the x-rays provided showed the bone near the resection had massive resorption, osteolysis and radiolucency, and the femoral stem clearly showed a horizontal fracture line at the middle of the stem which confirms the reason for revision.Product history review: review of the product history records indicate (b)(4) was manufactured and accepted into final stock on 28oct2014 with no reported discrepancies.Complaint history review: similar reported events regarding femoral stem fracture and loosening in jts distal femoral replacement.There have been 2 and 12 other events respectively.Conclusions: an event regarding fracture of a femoral stem in a jts distal femur was reported.The event was confirmed by medical review.During the clinician review loosening was also identified.The exact cause of the event could not be determined because further information such as pre-operative x-rays and the primary operative report as well 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 in a text message received by regional oncology specialist by surgeon: "this patient who had a stanmore put in.In 2014.He has reached maximal expansion and unfortunately this happened over the weekend (x-ray images show a broken femoral stem).Going to revise this to a stryker adult hopefully tomorrow (27/may/2020).Update 02jul2020 - during clinician review, it was reported that the bone near the resection had massive resorption, osteolysis and radiolucency.
 
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Brand Name
DISTAL FEMUR JTS - FEMORAL STEM
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 Key10175377
MDR Text Key195802524
Report Number3004105610-2020-00112
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
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPIN 18932
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 18932
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/26/2020
Initial Date FDA Received06/19/2020
Supplement Dates Manufacturer Received09/24/2020
Supplement Dates FDA Received10/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age18 YR
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