Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Device Dislodged or Dislocated (2923); Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Scar Tissue (2060); Discomfort (2330); Injury (2348); Joint Disorder (2373); Joint Dislocation (2374)
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Event Date 03/31/2009 |
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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Alleges that friction and wear caused large amount of metal ions and particles to be released into the patient¿s blood and tissue and bone surrounding the implant resulting to pain, injury, discomfort and inflammation.Doi: (b)(6) 2004; dor: (b)(6) 2009; right hip.
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Manufacturer Narrative
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Product complaint # = > pc-(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.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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Pfs has no new allegation.After review of medical records, patient was revised to address unstable thr.Revision notes reported of scar tissue and a lot of grumous within the joint.
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Event Description
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Medical record alleges dislocation.
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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.Udi: (b)(4).
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Event Description
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Ppf alleges metallosis.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: 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 will be filed as appropriate.
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Search Alerts/Recalls
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