STANMORE IMPLANTS WORLDWIDE JTS DRIVE UNIT SET; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number JTS-DRIVE-UNIT |
Device Problem
Failure to Advance (2524)
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Patient Problems
Unequal Limb Length (4534); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2022 |
Event Type
malfunction
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Event Description
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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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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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".
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Event Description
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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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Search Alerts/Recalls
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