SYNTHES GMBH PL 1-HO F/FEM NECK SYST TAN; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Catalog Number 04.168.000S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Necrosis (1971); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Udi: (b)(4) gtin unavailable, product made prior to gtin compliance date.Reporter is a j&j employee.(b)(4).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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Event Description
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Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent a surgery.After surgery, on (b)(6) 2022, necrosis of the femoral head was confirmed.There is a plan to perform a revision surgery via bha or tha, but it has not been decided at this point.Also to note is that necrosis of the femoral head is not due to an implanted product, and necrosis of the femoral head occurs at the time of injury or unavoidably after injury in most of the cases.No further information is available.This report is for one (1) pl 1-ho f/fem neck syst tan this is report 1 of 4 for complaint (b)(4).
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Search Alerts/Recalls
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