Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Tissue Damage (2104); Osteolysis (2377); Test Result (2695); No Code Available (3191)
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Event Date 04/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter: patient.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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Patient communication received.It was reported that the patient had a left hip revision caused by metal on metal depuy implant or products and patient will a have a right hip revision later.The surgeon suggest to call j and j rather than to contact law firm patient already contacted and wait for a text from the law firm.Instead, surgeon suggested to deal with j and j would be the smartest thing to do.Patient had osteolysis that caused major problem and metallosis and a very large chromium and cobalt blood regime.Doi: unknown, dor: unknown, left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).(b)(4) used to capture the surgical intervention.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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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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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