Catalog Number 121887352 |
Device Problems
Device Dislodged or Dislocated (2923); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 08/23/2017 |
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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Pinnacle claim submission form and medical records received.After review of medical records, the patient was revised to address dislocation, clicking, discomfort, bilateral lower extremity foot drop, pain, elevated blood metal ions and metal on metal reaction.Patient had stated that she felt that her hip has subluxed at times.Range of motion was noted to be limited.There was tenderness and weakness as well.Intraoperative findings include metallosis with "dish soap water fluid", a significantly abducted acetabular component and gross trunnionosis on the femoral head.During the revision surgery, patient had acute blood loss anemia secondary to the surgery.Two packed red blood cells were given.Doi: (b)(6) 2008.Dor: (b)(6) 2017, (right hip).
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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).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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