Attune claim letter received.Claim letter alleged that patient experienced severe and persistent pain, discomfort, instability, popping and clicking of his device, and difficulty ambulating caused by, among other things, the loosening, the lack of long-term fixation, debonding and migration of the defective tibial baseplate and attune device components.
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Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.The investigation could not draw any conclusions regarding the reported event.Depuy considers the investigation closed at this time.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, a follow-up medwatch will be filed as appropriate.
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