Patient height reported as 175.0 cms.Date of event reported as 2018, exact date patient infection began is not known.Additional product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.B5: updated info.H3, h4, h6: device history lot part: 413.035s lot: l755679 manufacturing site: selzach supplier: il-medtec ag release to warehouse date: 01.Feb.2018 expiry date: 01.Jan.2028 the sterilization history record shows that this lot of 238 pieces was processed through the normal sterilization and inspection operations with no non-conformity's noted.The irradiation certificate does certify that all readings are within the specified range.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.H3, h4, h6: investigation summary: 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.
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