Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 13 states, "intraoperative or postoperative bone fracture and/or postoperative pain." it also states, "intraoperative and early postoperative complications can include: "temporary or permanent nerve damage resulting in pain or numbness to the affected limb." medical products - access 3.2 mm thd steinmann 9", cat#: 110003484 lot#: 695560; compr nano 7in steinmann pin, cat#: 31-406990 lot#: 044320; cobalt hv bone cement 40g, cat#: 402282 lot#: 618180.This report is number 1 of 5 mdrs filed for the same patient (reference 1825034-2017-01369 - 01373).
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