STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 50MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 542-11-50E |
Device Problems
Malposition of Device (2616); Positioning Problem (3009); Noise, Audible (3273)
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Patient Problems
Inflammation (1932); Injury (2348); Reaction (2414)
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Event Date 05/27/2015 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There has been 1 other event for the lot referenced.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
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Event Description
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It was reported by the patient's attorney as a result of a legal claim that allegedly following the implantation, the patient began experiencing "squeaking and grinding" in her hip which has been getting progressively worse.It is further alleged that her doctor was concerned about the potential of metal on metal grinding in the metal implant and metal toxicity and as a result of her serum metal levels and changes on her mars mri, the patient underwent a revision on her right total hip arthroplasty on (b)(6) 2015.Event update per review of the medical records: [.] "malposition of the acetabular shell and retroversion at the primary total hip arthroplasty resulted in rim wear of the poly insert and metal/metal impingement of the stem on the acetabular metal rim.".
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Manufacturer Narrative
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An event regarding alleged malposition of the shell, worn poly liner and abnormal ion levels involving a trident shell was reported.The event was confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: a review of the primary and revision operative reports, office notes and x-rays by the consulting clinician indicated "there is no examination of the explanted components and there is no description of trunnion corrosion at the revision surgery, with a new ceramic head directly applied to the retained stem.Malposition of the acetabular shell and retroversion at the primary total hip arthroplasty resulted in rim wear of the poly insert and metal/metal impingement of the stem on the acetabular metal rim.This resulted in the modest increased cobalt and chromium levels and the metallosis of the adjacent soft tissue noted at revision surgery.This was addressed by inserting an eccentric liner to avoid impingement rather than repositioning the well fixed shell.After revision the cobalt and chromium levels returned to normal.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical event." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been 1 other event for the lot referenced.Conclusions: the event was confirmed based on review of the primary and revision operative reports, office notes and x-rays by the consulting clinician indicating "malposition of the acetabular shell and retroversion at the primary total hip arthroplasty resulted in rim wear of the poly insert and metal/metal impingement of the stem on the acetabular metal rim.This resulted in the modest increased cobalt and chromium levels and the metallosis of the adjacent soft tissue noted at revision surgery.This was addressed by inserting an eccentric liner to avoid impingement rather than repositioning the well fixed shell.After revision the cobalt and chromium levels returned to normal.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical event." if the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
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Event Description
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It was reported by the patient's attorney as a result of a legal claim that allegedly following the implantation, the patient began experiencing "squeaking and grinding" in her hip which has been getting progressively worse.It is further alleged that her doctor was concerned about the potential of metal on metal grinding in the metal implant and metal toxicity and as a result of her serum metal levels and changes on her mars mri, the patient underwent a revision on her right total hip arthroplasty on (b)(6) 2015.Event update per review of the medical records: [.] "malposition of the acetabular shell and retroversion at the primary total hip arthroplasty resulted in rim wear of the poly insert and metal/metal impingement of the stem on the acetabular metal rim.".
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