Catalog Number UNK HIP FEMORAL AUGMENT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Anemia (1706); Edema (1820); Foreign Body Reaction (1868); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Pain (1994); Renal Failure (2041); Sepsis (2067); Distress (2329); No Code Available (3191)
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Event Date 11/09/2018 |
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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Revision due to pain and infection.Doi: 2006; dor: (b)(6) 2018; left hip.
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Manufacturer Narrative
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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.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, a follow-up medwatch will be filed as appropriate.
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Event Description
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Litigation alleges pain, swelling, redness, infected hip joint, elevated crp and metal ions.According to operative report found streptococcus pneumoniae in multiple sites in the joint.Noted abscess cavity and pus.Plaintiff also suffered and experienced acute kidney injury, cardiomyopathy, hypertension, anemia, infectious disease, sepsis, metallosis, emotional distress and mental trauma.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
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Manufacturer Narrative
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H10 additional narrative: product complaint # = > pc-(b)(4).Investigation summary = > reopen: jan 31, 2020 no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > null.Device history batch = > null.Device history review = > null.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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