(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: update (b)(6) 2021: the investigation was re-opened due to device returned.Examination of the returned device confirmed the reported event.The noted damage is attributed to a combination of wear out over the cycle life of the device and material overload during the usage in the field.The investigation did not establish a need for corrective action.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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