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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 Failure to Advance (2524)
Patient Problems No Known Impact Or Consequence To Patient (2692); Cancer (3262)
Event Date 05/04/2020
Event Type  malfunction  
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: "surgeon is reporting that the patient's [right side] jts device (stanmore pin 20350) is not lengthening. Device was reportedly lengthening fine for 3+ years (35mm) after surgery. Surgeon said that all of a sudden, they went to lengthen him, everything sounded fine, then all of a sudden the noise audibly changed, and the gearbox seemed to stop running. Walking with slight limp due to leg length discrepancy. ".
 
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Brand NameDISTAL FEMUR JTS
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 WD6 3-SJ
GB   WD6 3SJ
2082386500
MDR Report Key10106724
MDR Text Key194141637
Report Number3004105610-2020-00097
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133152
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2017
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 20350
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2016
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: 06/01/2020 Patient Sequence Number: 1
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