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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) - CAP; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) - CAP; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Injury (2348); Ambulation Difficulties (2544); Cancer (3262)
Event Date 01/29/2020
Event Type  malfunction  
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.Device not returned.
 
Event Description
It has been reported that there has been disassembly between the cap and the femoral component.As reported: "yesterday i had a problem with the pin 21300 extension case.The medial locking screw was removed in the operation and the extension port was rotated 70 x 360 degrees clockwise.We found that there was no extension.Then we rotated 100 x 360 degrees counterclockwise and the extension port came out of the socket.We put it back in the nest.The medial locking screw is tightened instead, we left the extension port stable".
 
Manufacturer Narrative
Reported event: an event regarding disassociation involving a mig distal femoral replacement was reported.The event was not confirmed.Method and results product evaluation and results: not performed as no items were returned.Clinician review: the implant in situ was for a mig distal femoral replacement which was originally inserted on (b)(6) 2018 and a subsequent surgery was performed recently with an intention to extend the implant.The surgeon reported that the implant has failed to extend.Some of the pictures taken during surgery show that the components for extension were not damaged and the reason for the implant not extending cannot be assessed from the pictures provided.In addition, there is no x-ray images being provided to confirm that the implant has not been extended.Therefore, more information is required to confirm the clinical report.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 08may2018 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01jan2017 to present for similar reported events regarding component disassociation due to user error involving mig devices.There has been no other event.Conclusion: the investigation concluded that the device failure was caused by a user error.The sales rep reported on the (b)(6) 2020 that the lengthening procedure was unsuccessful: the locking screw mechanism was removed, the prosthesis failed to extend and the cap and screw were disassembled from the main device by turning counter-clockwise.This caused a delay of 2 hours.A second unsuccessful lengthening procedure was reported on the (b)(6).2020.The senior manager (design engineering) reviewed the event and stated that the sales rep did not follow the minimally invasive grower instructions for adjustment, since the locking screw was completely removed.This was then communicated to the sales rep, who confirmed the error.After the second unsuccessful lengthening procedure, the senior manager (design engineering) suggested to revise the device since the mechanism was damaged during the first lengthening procedure.
 
Event Description
It has been reported that there has been disassembly between the cap and the femoral component.As reported: "yesterday i had a problem with the pin 21300 extension case.The medial locking screw was removed in the operation and the extension port was rotated 70 x 360 degrees clockwise.We found that there was no extension.Then we rotated 100 x 360 degrees counterclockwise and the extension port came out of the socket.We put it back in the nest.The medial locking screw is tightened instead, we left the extension port stable".As per sales rep email, there was a delay of 2 hours.
 
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Brand Name
DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) - CAP
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 Key9756394
MDR Text Key189990215
Report Number3004105610-2020-00038
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 04/08/2020
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 Catalogue NumberUNK_STM
Device Lot NumberPIN 21300
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/29/2020
Initial Date FDA Received02/26/2020
Supplement Dates Manufacturer Received03/31/2020
Supplement Dates FDA Received04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age25 YR
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