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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE JTS DRIVE UNIT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE JTS DRIVE UNIT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number JTS-DRIVE-UNIT
Device Problem Failure to Advance (2524)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2020
Event Type  malfunction  
Manufacturer Narrative
Please note that this event is related to a jts drive unit which is used in conjunction with the jts non-invasive extendible implant (k092138) 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 inspection records indicates the device conformed to requirements, as reported in the annual maintenance performed on the 10th of march 2020.
 
Event Description
As reported by a marketing associate: "we have been informed that in a new elongation procedure, again we have not had any extension. A clinician assessment was provided which outlines the following: implant date (b)(6) 2018, left femur. In (b)(6) 2019, 7-8mm extension was achieved in two sessions, 16 minutes each. In (b)(6) 2019, patient had a metastatic recurrence of cancer and underwent chemotherapy. Treatment completed in (b)(6) 2020. In (b)(6) 2020, on three different days, attempts were made to lengthen the implant unsuccessfully ("to an average of 16 minutes (4mm) without getting the prosthesis to lengthen"). The drive unit had last been serviced in (b)(6) 2020.
 
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Brand NameJTS DRIVE UNIT
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
UK WD6 3SJ
Manufacturer (Section G)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK WD6 3SJ
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key10209127
MDR Text Key213677051
Report Number3004105610-2020-00114
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeES
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 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberJTS-DRIVE-UNIT
Device Lot Number907-250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/29/2020 Patient Sequence Number: 1
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