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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE JTS DRIVE UNIT SET; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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STANMORE IMPLANTS WORLDWIDE JTS DRIVE UNIT SET; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number JTS-DRIVE-UNIT
Device Problem Failure to Advance (2524)
Patient Problems Unequal Limb Length (4534); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Event Description
Rep reported that there was a failed lengthening of the patient's distal femur jts.Rep was not present for the attempted lengthening but as a matter of course sends an email with pictures explaining all of the correct steps for a lengthening, including using the direction as reported in the design proposal and aligning the external and internal magnets.Surgeon wants to obtain another drive unit to lengthen the existing implant.
 
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 (b)(4)).Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Manufacturer Narrative
Reported event: an event regarding non functionality involving a jts, drive unit was reported.The event was confirmed by functional inspection.Method & results: device evaluation and results: visual inspection: visual inspection of the jts coil reported, showed small scratches on the rim of the coil and a small plastic kids sticker covering the device description panel.On the back of the power unit, the plastic covering protecting the boost feature is broken.Both the magnetic coil and the power unit console share the same serial number ¿(b)(6)¿ and both devices state the date of manufacture is ¿may-16¿.Functional inspection: review of the annual maintenance and functional inspection indicates the device did not pass functional inspection, under the comments / observation section it states " no rotation on polarity test.Unable to test further".Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the annual maintenance and functional inspection indicates the device successfully passed functional inspection.No comments/ observations.Complaint history review: there has been 1 other event.Conclusion: it was reported drive unit (b)(6) did not pass the functional inspection and under the comments/ observation section it states " no rotation on polarity test.Unable to test further" on 12may2022 an update was provided the magnet that was has been sent in for repair [.] the investigation concluded that unsuccessful lengthening procedure reported on (b)(6) 2022 was caused by a non functional drive unit.Inspection of the device confirmed "no rotation on polarity test".
 
Event Description
Rep reported that there was a failed lengthening of the patient's distal femur jts.Rep was not present for the attempted lengthening but as a matter of course sends an email with pictures explaining all of the correct steps for a lengthening, including using the direction as reported in the design proposal and aligning the external and internal magnets.Surgeon wants to obtain another drive unit to lengthen the existing implant.
 
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Brand Name
JTS DRIVE UNIT SET
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
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 Key14235733
MDR Text Key290266645
Report Number3004105610-2022-00063
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberJTS-DRIVE-UNIT
Device Lot Number907-502
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age15 YR
Patient SexMale
Patient Weight50 KG
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