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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE JTS DISTAL FEMUR - LEAD SCREW PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE JTS DISTAL FEMUR - LEAD SCREW PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problems Insufficient Information (3190); Difficult or Delayed Separation (4044)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 03/25/2020
Event Type  malfunction  
Manufacturer Narrative
The following devices were also listed in this report: jts distal femur - distal component; pin 19569. Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. 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
During a revision of the patient's right distal femur (stryker ref 20192267738, fda ref 3004105610-2019-00141 sent 20dec2019), the surgeon reported the following: "first problem: after the smiles knee was disassembled, it was not so easy to slide out the distal femoral component in situ. It was necessary to use a hammer to give a little shock to slide it out. It is only a little problem". "second problem: the leadscrew was blocked into the piston in-situ. I have used the alignment tool as recommended by you. But i tried to unscrew the leadscrew with the alignment tool, but the square peg on the top of the alignment tool twisted. It was finally possible to unscrew the leadscrew by using a self-grip pliers. I replaced it by the new lead screw and it was easy to screw the new lead screw without forcing. But as the square peg was twisted, it was not so easy to align the two components, but i finally succeeded to do it. As the leadscrew was difficult to extract, there was a surgical delay of around 10 to 15 minutes. ".
 
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Brand NameJTS DISTAL FEMUR - LEAD SCREW
Type of DevicePROSTHESIS, 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
Manufacturer (Section G)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
GB WD6 3SJ
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood, FL WD6 3-SJ
GB   WD6 3SJ
9546280700
MDR Report Key9989759
MDR Text Key214825081
Report Number3004105610-2020-00085
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K133152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 19569
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/23/2020 Patient Sequence Number: 1
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