WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
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Device Problem
Break (1069)
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Patient Problems
Failure of Implant (1924); 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 plate/ 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.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 an unknown date, the patient underwent a revision of a broken variable angle condylar plate on a periprosthetic femur fracture.It was replaced with a new plate and bone graft.Original date of surgery was on (b)(6) 2016.The revision surgery was performed and completed without complications.There was no patient consequence.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.
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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.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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