Model Number 1365-36-730 |
Device Problems
Device Dislodged or Dislocated (2923); Noise, Audible (3273)
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Patient Problems
Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191)
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Event Date 12/19/2016 |
Event Type
Injury
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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.Device was used for treatment, not diagnosis.(b)(4).
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Event Description
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Ppf and sticker sheets received.Ppf alleges dislocation with closed reduction and elevated metal ions.After review of medical records, patient was revised to address recurrent dislocations.Doi: (b)(6) 2014 - dor: (b)(6) 2016 (right hip).
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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.Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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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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 caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 and h6 no code available use for device revision or replacement.
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Event Description
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Pfs alleges pain, walking difficulty and clunking after first revision.There were no revision notes reported.Doi: (b)(6) 2014 dor: (b)(6) 2016 right hip.
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Search Alerts/Recalls
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