Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); No Code Available (3191)
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Event Date 12/06/2018 |
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.
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Event Description
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Painful post-op.This case is from health authority.It was reported that the patient was given bilateral total hip arthroplasty in 1999, and the postoperative recovery was smooth.Left hip revision was performed in 2009.On (b)(6) 2018, the patient suffered from a fall and felt painful in the right lower limb, x-ray showed fracture of right upper femur.The patient was given the incision of right femur under general anesthesia, reduction of internal fixation and revision of the right total hip joint on (b)(6), pe liner was observed with obvious eccentric damaged, a large number of pale yellow inflammatory pseudotumor, the patient recovered smoothly after surgery.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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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Search Alerts/Recalls
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