Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pulmonary Embolism (1498); Cardiac Arrest (1762); Infarction, Cerebral (1771); Tissue Damage (2104); Test Result (2695)
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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.
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Event Description
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Ppf alleges stroke/heart attack, pulmonary embolism, metal wear, metallosis and elevated metal ions.Doi: (b)(6) 2008.Dorl none reported.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.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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