Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)
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Patient Problems
Bone Fracture(s) (1870); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 03/08/2011 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(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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Update 17 aug 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and sticker sheets.In addition to what previously alleged, ppf alleges fracture component and loosening of stem.Added account name, law firm, date of revision, date of birth and age of patient.Also added unknown stem and unknown hip implant has been added to captured the allegation of a fracture as its unknown where the fracture was.If/when more information is received, the pc will be updated as needed.Corrected date of event.Doi: (b)(6) 2005; dor: (b)(6) 2011, right hip.
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Event Description
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Ppf alleges fracture component of the stem.
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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.
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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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.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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