Catalog Number UNK_SEL |
Device Problem
Device Inoperable (1663)
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Patient Problem
Unspecified Infection (1930)
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Event Date 04/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
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Event Description
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It was reported via fda mw# 5068829: then in (b) (6) of 2016 an infection setup in the hardware in the shoulder.They did another surgery to flush the shoulder and put me on 2 different antibiotics to get the infection under control.That did not work.They took out all the stryker hardware out, flushed and put in an antibiotic shim in its place.At that time i was put on daily iv antibiotics for 6 weeks.Then on (b)(6) 2017, they put all new hardware in from a different mfr and added another 4 weeks of iv antibiotics and that is to today¿s date (b)(6) 2017.
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Manufacturer Narrative
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Referring to the product inquiry all reported products are considered primary products.No further associated products were reported.The devices were not returned to stryker kiel.A review of the device history records was not possible since the lot codes of the reported products are unknown.The x-rays and medical records provided were forwarded to a consulting health care professional for review.His comments (excerpts): assessment: the primary harm involved is peri-prosthetic infection of a reverse total shoulder arthroplasty.The patient had multiple risk factors for infection including underlying rheumatoid arthritis which is an auto immune disease, trauma leading to an orif and multiple subsequent revision surgeries.The organism involved propionibacterium.A recent current concepts review in the journal of bone and joint surgery outlines the prevalence of this organism involving infections of the shoulder.It is a commensal organism found within the skin of patients undergoing procedures in this area.There is no evidence to suggest a defect in the implants or their manufacture.¿ a review of the event in line with ¿(b)(4) infection complaints checklist investigator¿ was not expedient since all product data of the reported devices are unknown.The completed ¿(b)(4) infection complaints checklist customer¿ was deemed not necessary in this case since the organism involved was already identified by the id specialist and considered to be ¿a commensal organism found within the skin of patients undergoing procedures in this area¿ by the consulting health care professional.Review of the complaint history and capa databases was not possible due to missing product data, but was already deemed dispensable since the products were not suspected to have contributed to the reported event.Based on the above the root cause of the reported event is not linked to a deficiency of the devices but is rather considered patient related.No nonconformity was identified.
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Event Description
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It was reported via fda mw# 5068829: then in (b)(6) of 2016 an infection setup in the hardware in the shoulder.They did another surgery to flush the shoulder and put me on 2 different antibiotics to get the infection under control.That did not work.They took out all the stryker hardware out, flushed and put in an antibiotic shim in its place.At that time i was put on daily iv antibiotics for 6 weeks.Then on (b)(6) 2017, they put all new hardware in from a different mfr and added another 4 weeks of iv antibiotics and that is to today¿s date (b)(6) 2017.
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Search Alerts/Recalls
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