Index operation on (b)(6) 2021, acetabular cup implanted with incorrect inclination, patient was dislocating superiorly.50mm pinnacle sector cup explanted and revised to a 52mm pinnacle multihole cup with pinnacle dual mobility due to concerns around stability.Doi: (b)(6) 2021.Dor: (b)(6) 2021.Unknown side.
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot: a worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
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