DEPUY ORTHOPAEDICS, INC. 1818910 SROM STM ST,36+6L NK,11X16X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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Catalog Number 563517 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Hypoesthesia (2352); Test Result (2695); Not Applicable (3189)
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Event Date 10/31/2011 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Reporter is an attorney.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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Litigation alleges severe pain, discomfort, inflammation, elevated metal ions, metallosis and, a 'clanking' noise in the right hip.Doi: (b)(6) 2006 - dor: (b)(6) 2011; (right side).
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Manufacturer Narrative
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Udi: (b)(4).
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Event Description
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Pfs alleges numbness and spasm.After review of medical records, patient was revised to address right hip pain status total hip, possible metal reaction.Revision notes reported a capsulotomy was performed revealing fluid.It looked like a slight metal reaction type fluid.
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Manufacturer Narrative
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Product complaint #: (b)(4).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.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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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.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.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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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