SMITH & NEPHEW, INC. UNKNOWN SUSPENSORY FIXATION DEVICE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 01/01/2005 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference case (b)(4).Doi: 10.1016/j.Arthro.2004.10.017.Prodromos, c.C., han, y.S., keller, b.L., & bolyard, r.J.(2005).Stability results of hamstring anterior cruciate ligament reconstruction at 2-to 8-year follow-up.Arthroscopy: the journal of arthroscopic & related surgery, 21(2), 138-146.
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Event Description
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It was reported that on literature review "stability results of hamstring anterior cruciate ligament reconstruction at 2- to 8-year follow-up", after surgery with an endobutton, 1 patient experienced deep vein thrombosis which was treated with anticoagulants.No further information is available.
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Manufacturer Narrative
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H10: h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The data presented in the aged article does not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.Therefore, no further medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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