Catalog Number 999890249 |
Device Problems
Nonstandard Device (1420); Naturally Worn (2988)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Joint Disorder (2373); Test Result (2695); No Code Available (3191)
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Event Date 02/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Occupation is a non-healthcare professional.(b)(4).
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Event Description
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Revision due to pain, pseudotumor, metal wear, and elevated metal ions.Doi: (b)(6) 2007; dor: (b)(6) 2018; right hip.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.
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Search Alerts/Recalls
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