ASCENSION ORTHOPEDICS, INC. UNKN PIP IMPL; HIGH DEMAND, REVISION,SEMI-CONSTRAINED,PYROLYTIC CARBON,UNCEMENTEDFINGERPRO
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Catalog Number UNKNOWN |
Device Problem
Migration (4003)
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Patient Problem
Urticaria (2278)
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Event Date 07/01/2014 |
Event Type
Injury
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Manufacturer Narrative
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Internal reference number: (b)(4).Doi: https://doi-org.Ezproxy.Uvm.Edu/10.1177/1753193413479527.This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
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Event Description
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It was reported that on literature review "ten years¿ experience with a pyrocarbon prosthesis replacing the proximal interphalangeal joint.A prospective clinical and radiographic follow-up", about two-thirds of the implants were in the stern grade 1 for migration (macroscopically evident migration) and about 20% of the implants were in the stern grade 2 for migration (severe migration with stem opposing cortex, but without breaching the cortex).The volume of patients affected by this adverse event was provided in percentage and in terms of adverse event per implant, instead of adverse event per system.As it is not possible to know the quantity of systems involved (fingers), we are assuming the worst case scenario.The current state of health of the patients is unknown.No further information is available.
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Search Alerts/Recalls
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