WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - RADIAL HEAD PROSTHESIS: RADIAL STEM; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
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Device Problem
Unintended Movement (3026)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown radial head prosthesis radial stem/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.(b)(4).Device was used for treatment, not diagnosis.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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It was reported that on (b)(6) 2017, patient underwent a procedure wherein the radial head and stem were replaced.The patient was reportedly fell and sustained a bone fracture.The date as to when the devices were implanted was unknown.The patient was then implanted with two (2) 2.0 mm screws, four (4) locking screws, two (2) compression screws, one (1) 4 hole 2 mm plate and one (1) olecranon plate.It is unknown if there was a surgical delay.Patient outcome is unknown.This report is for one (1) unk - radial head prosthesis: radial stem.This is report 2 of 2 for (b)(4).
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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.Concomitant medical products: complainant part is not expected to be returned for manufacturer review/investigation.Device was used for treatment, not diagnosis.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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