It was reported that on (b)(6) 2023, the surgeon¿s office staff requested the metal composition for implants used on a patient.The patient was experiencing swelling, redness and irritation in his abdomen.The requested information for depuy expedium and legacy synthes - metal composition breakdowns was provided.Late the patient was referred to a dermatologist and surgeon¿s office asked if patch test kit could be provided.This report is for one (1) 5.5 exp verse unitized set scr.This is report 6 of 10 for complaint (b)(4).This complaint is related to (b)(4), and (b)(4).
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b3: event year is reported as 2023, however exact date of on set of patient's swelling, redness and irritation in abdomen is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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