Catalog Number 542-11-52E |
Device Problems
Mechanical Problem (1384); Malposition of Device (2616); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
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Patient Problems
Injury (2348); Joint Dislocation (2374)
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Event Date 12/02/2013 |
Event Type
Injury
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Event Description
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It was reported that the patient suffered a dislocation of a left hip constrained liner.The acetabular component was revised.
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Manufacturer Narrative
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Catalogue number unknown at this time.Device description reported as an unknown liner.An evaluation of the device cannot be performed as the device was discarded and was not returned to the manufacturer.Additional information (including x-rays and medical records) has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Manufacturer Narrative
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An event regarding dislocation involving a trident psl ha cluster 50mm and a citation tmzf ha stem #3 right (cat # 6265-5113 lot # 42645801 description: citation tmzf ha stem #3 right) was reported.The event was confirmed.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated that the root cause of the dislocation was a malpositioned shell.Furthermore the implantation of a right femoral stem in a left hip may have led to instability contributing to the dislocation.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: a complaint history review confirmed no other similar events for the reported lot.Conclusions: the investigation concluded that the dislocation was caused by a malpositioned acetabular shell in tandem with an incorrect side femoral stem.There is no indication that the reported event was device related.
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Event Description
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It was reported that the patient suffered a dislocation of a left hip constrained liner.The acetabular component was revised.
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Manufacturer Narrative
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Device history review: review of the device history records indicate devices were manufactured and accepted into final stock.Complaint history review: there have been no other events reported for the reported manufacturing lot.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿principal root cause of failure was cup malposition leading to impingement and recurrent dislocation.The first revision with exchange of the regular trident liner to a constrained liner only made things worse due to the reduced rom effects of such constrained liners while the second revision did a better job by addressing the underlying cup malposition problem.Because cup position was the principal problem and the surgeon is responsible for optimal component placement, principal root cause of failure is procedure-related with the instability further aggravated by another procedure-related effect related to early postoperative muscular laxity as caused by the previous arthroplasty procedure and an additional patient-related factor of muscular atrophy due to high patient age.This failure scenario applies to the first revision (pi) but because the root cause of failure was not addressed during the first revision, a second revision surgery became necessary (pi) also the second revision has exactly the same root cause of failure relating to persistence of present underlying instability factors including cup malposition.No indications for presence of device-related factors were seen and as such root cause of failure for both listed pi cases is not device-related.A review of the provided medical records by a clinical consultant indicated that the root cause of the dislocation was a malpositioned shell.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.
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Event Description
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It was reported that the patient suffered a dislocation of a left hip constrained liner.The acetabular component was revised.
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Search Alerts/Recalls
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