Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Attorney.
|
Litigation alleges that the corrosion and friction wear caused toxic cobalt-chromium metal debris to be released into the plaintiff's tissue surrounding the implant.It is further alleged that the plaintiff experienced pain, metallosis, injury, partial or complete loss of mobility and loss of range of motion.
|