Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hearing Impairment (1881); Tissue Damage (2104); Injury (2348); Test Result (2695); No Code Available (3191)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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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Patient indicated she experienced boils, hearing loss, irregular heart beat and heart tissue changes, kidney pain, joint pain, mood/behavioral problems, soft tissue injury and elevated ions. .
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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 code(s) 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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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