Model Number 1217-22-052 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Pocket Erosion (2013); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 07/20/2015 |
Event Type
Injury
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Manufacturer Narrative
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(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, it was stated that the patient was revised to address aseptic loosening.Patient also complains pain and discomfort.Revision notes reported a pseudotumor-type fluid, extreme amount of tissue destruction, black metallossis, atrohpied and fatty muscles, necrotic tissues, osteolysis, semi-contained defect in the acetabulum, loose acetabular component, eroded away and resolved proximal femoral trochanter, and erosion of the bone.A small amount of splintering of the proximal bone but was not displaced resulted when the stem was being removed.All devices were explanted and replaced with competitor.Doi: (b)(6) 2010; dor: (b)(6) 2015; left 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).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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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