It was reported that when attempting to impact the delta humeral poly cup into the delta humeral stem, the poly wouldn't completely seat, even after multiple attempts.The surgeon suggested the locking mechanism was defective and demanded another poly cup.A 5 minutes surgical delay was noted.Doe: (b)(6) 2020, left knee.
|
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary =the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = the dhr analysis of the batch returned shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or nonconformance.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|