Product complaint (b)(4) h6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary according to the information received, it was reported that the patient was revised due to liner disassociated from cup.No device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device lot number: m0313u, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot a manufacturing record evaluation was performed for the finished device lot number: m0313u, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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