Catalog Number 563618 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Scar Tissue (2060); Osteolysis (2377); Test Result (2695); No Code Available (3191)
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Event Date 11/30/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(b)(4).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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Event Description
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After review of medical records, the patient was revised to address metal toxicity and progressive pain.X-rays were taken prior to the revision revealing what looked like a large bubble of osteolysis over the lateral shoulder of the implant as well as some flattening of the calcar.Operative findings include a large pocket of bursal fluid containing about 10 cc of clear, straw colored fluid.There was a significant amount of sandy-type material over the areas correlating with the osteolytic area on the x-ray.Finally, there were some scar tissue and a small amount of granulation tissue between the cup and liner.Doi: (b)(6) 2009 - dor: (b)(6) 2016 (left hip).
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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 complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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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