WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI STRAIGHT RADIAL STEM 32MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER
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Model Number 04.402.010S |
Device Problem
Unintended Movement (3026)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Date 01/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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) 2019, the patient underwent an elbow radial head replacement surgery due to the loosening of the radial head prosthesis as confirmed through x-ray on an unknown date.On or about (b)(6) 2016, the patient was implanted with a depuy synthes radial head implant system.Postoperatively, patient experienced increasing pain, loss of range of motion, weakness of right elbow and surrounding regions and decreased function of the elbow.It was unknown if the surgery was completed successfully with or without delay.The patient outcome was unknown.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity unknown).This complaint involves two (2) devices only.This report is for (1) 10mm ti straight radial stem 32mm-sterile.This is report 2 of 2 for (b)(4).
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