Model Number 1217-22-052 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 03/13/2014 |
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.Occupation: lawyer.
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Event Description
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After review of medical records, the patient was revised to address septic loosening.Operative findings include inflammatory tissues, loose cup as well as stem, a large fluid collection within the joint and necrotic tissue.Revision implants are from depuy.Antibiotic-laden cement was used on the acetabulum and femoral canal.These were removed 3 months after as planned with no complications.
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Manufacturer Narrative
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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.H6 patient code: no code available (3191) used to capture the fat necrosis.
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Search Alerts/Recalls
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