Catalog Number UNK HIP FEMORAL AUGMENT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 02/01/2008 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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The literature article entitled, "treatment of intertrochanteric nonunion of the proximal femur using the s-rom prosthesis" written by carl t.Talmo, md and james v.Bono, md published by orthopedics 2008;31(2) https://doi.Org/10.3928/01477447-20080201-35 posted online 1 february 2008 was reviewed.The article's purpose was to discuss results of utilizing srom prosthesis in revision surgeries treating intertrochanteric nonunion of the proximal femur.Depuy products utilized: srom stem.Adverse events: blood transfusions, peroneal nerve palsy (re-occurrence from initial surgery) that self resolved completely within 6 weeks, postoperative delirium that resolved with minor medication adjustments, intermittent activity-related pain (no intervention and no revision).
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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