Catalog Number 625-0T-28D |
Device Problems
Migration or Expulsion of Device (1395); Scratched Material (3020)
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Patient Problem
Injury (2348)
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Event Date 08/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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Tha primary surgery was performed on (b)(6)2010.Then the revision surgery was performed on (b)(6)2017 because the ceramic liner had deviated to superior approximately 5 degrees.All implants except the stem were replaced.
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Event Description
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Tha primary surgery was performed on (b)(6) 2010.Then the revision surgery was performed on (b)(6) 2017 because the ceramic liner had deviated to superior approximately 5 degrees.All implants except the stem were replaced.
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Manufacturer Narrative
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An event regarding instability involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual inspection was performed on the returned device by a material analysis engineer which noted; the proximal and distal surface of the titanium sleeve showed signs of explantation damage.It was observed that the distal surface of the ceramic insert had metal transfer marks likely from explantation.[.] a material analysis was performed on the returned device which concluded [.] the acetabular shell, trident insert and alumina head showed signs of explantation damage.A continuous metal transfer ring was observed on the internal circumference of the female taper consistent with proper seating between of the trunnion of the hip stem and the head taper.No material or manufacturing defects were observed on the surfaces examined.[.] -medical records received and evaluation: a review of the provided x-rays and mar by a clinical consultant noted the following; [.] procedure-related factors: - none evident.Patient-related factors - soft tissue/muscle insufficiency across hip joint.Device-related factors: - none as also supported by mar findings.Diagnosis: - soft tissue/muscle insufficiency across hip joint has contributed to micro-instability in the arthroplasty with micro-separation as result causing an overload condition in the arthroplasty with osteolysis and probably cup loosening requiring revision.[.] -device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusion: a review of the provided x-rays and mar by a clinical consultant concluded [.] - soft tissue/muscle insufficiency across hip joint has contributed to micro-instability in the arthroplasty with micro-separation as result causing an overload condition in the arthroplasty with osteolysis and probably cup loosening requiring revision.[.] no further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.
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Search Alerts/Recalls
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