Catalog Number UNK_LIM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Date 03/01/2012 |
Event Type
Injury
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Event Description
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As per op report, "patient had i&d and replaced poly and bushings of the knee.".
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Manufacturer Narrative
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The patient is (b)(6) inches in height.An event regarding infection involving an unknown insert was reported.The event was confirmed.Method and results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated that this complicated, multiply revised total knee arthroplasty was entirely the result of the persistent periprosthetic infection.Device history review: not performed as the lot id was not provided.Complaint history review: not performed as the lot id was not provided.Conclusions: based on clinical review of the provided medical results concluded that there is no evidence that this clinical picture was the result of factors of faulty component design, manufacturing, or materials.A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control.
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Event Description
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As per op report, "patient had i&d and replaced poly and bushings of the knee.".
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Manufacturer Narrative
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During a review of medical records for a previously reported event, it was discovered that the patient had an i & d at which time the surgeon replaced an unknown poly liner and two unknown bushings.The catalog numbers and lot codes of these revised devices were not provided.Based on the limited information provided, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.
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Search Alerts/Recalls
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