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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL FEMUR MINIMALLY INVASIVE GROWER (MIG); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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STANMORE IMPLANTS WORLDWIDE PROXIMAL FEMUR MINIMALLY INVASIVE GROWER (MIG); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number UNK_STM
Device Problem Collapse (1099)
Patient Problems Injury (2348); Unequal Limb Length (4534)
Event Date 08/03/2020
Event Type  Injury  
Manufacturer Narrative
The reported device is similar to a device approved for compassionate use in the united states.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 prescription form has been received for the patient's left proximal femur.Noted: "minimally invasive grower.Now collapsed.Needs a non-invasive grower to get to final length.Presently about 6 cm short, with a final predicted length difference of 8-10 cm from present collapsed position.".
 
Manufacturer Narrative
An event regarding non functional involving a mig proximal 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: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for a mig proximal femoral replacement which was inserted on (b)(6) 2016.The surgeon reported a collapse of the implant causing 6cm of leg length discrepancy.The ct scan provided shows that there is no extension gap to be seen in the implant indicating a collapse if the implant has been extended before.The implanted femur measured 6cm shorter than the opposite femur, which confirm the surgeon¿s report and reason for revision.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 11may2016 with no reported discrepancies.Complaint history review: 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.
 
Event Description
A patient specific prescription form has been received for the patient's left proximal femur.Noted: "minimally invasive grower.Now collapsed.Needs a non-invasive grower to get to final length.Presently about 6 cm short, with a final predicted length difference of 8-10 cm from present collapsed position.".
 
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Brand Name
PROXIMAL FEMUR MINIMALLY INVASIVE GROWER (MIG)
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK  WD6 3SJ
MDR Report Key10468690
MDR Text Key204866387
Report Number3004105610-2020-00135
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 11/20/2020
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 Catalogue NumberUNK_STM
Device Lot NumberPIN 20129
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/03/2020
Initial Date FDA Received08/28/2020
Supplement Dates Manufacturer Received11/10/2020
Supplement Dates FDA Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age11 YR
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