It was reported that while the femur block worked like it¿s supposed to, the tibia block put the tibia into varus, so now he¿s having to recut and rebalance the knee.Currently trialing with a 10 poly which he almost never gets to.He also just called xray into the room to check his alignment.4 out of the last 5 cases now he¿s had issues with the trumatch blocks.".
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.No evidence was found indicating product error was a contributing factor to the reported event.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 info be received, the investigation will be re-opened as necessary.Device history lot : a device history record (dhr) review was performed.The review found one non-conformance (nr-0138283) against the provided lot number.The nr was for a batch of resin not meeting a material specification, and it is not related to the current reported event of the tibia block putting the tibia into varus.
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