Product complaint#: (b)(4).Investigation summary: the device associated with this report was received for examination.Visual inspection of the physical device found the device was threaded off axis/mispositioned and the hexagonal hole was stripped/worn, making it unable to disassemble from mating device.The reported condition was confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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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Intraoperatively, after impacting the cup and screwing in the hole eliminator, the surgeon wanted to correct the position of the cup.In order to insert the cup impactor, the apex hole eliminator should have been removed, which unfortunately was not possible.The surgeon decided to insert the inlay and reposition the hip.As a result of the trial reposition the hip dislocated and the cup was completely changed.No patient harm reported.
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