Product complaint # (b)(4).Component code: appropriate term/code not available (g07002) used to capture no findings available.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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy 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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that this was a primary surgery performed on (b)(6) 2019.After surgery, it was confirmed that greater tubercle was atrophied.Therefore, the implants will be removed, and rsa will be performed by other company¿s product.The revision surgery date is (b)(6) 2023.During the primary surgery implant insertion, a crack was confirmed in the greater tubercle.The surgeon commented that the crack was a possible cause other than the products.No further information is available.
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