Revision due to ceramic liner fracture.The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Engineering evaluation noted that the revision was likely the result of fracture of the insert.The patient's job as a laborer, and the associated heavy lifting may have contributed to the fracture but no truma was reported.Due to the missing fragments and secondary damages, a conclusion cannot be drawn regarding a possible cause for the fracture of the insert.
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After further review of additional information received the following sections b4, b5, d4, e2, g3, g4, g5, h2, h3, h4 and h6 have been updated accordingly.The revision reported in this event was likely the result of fracture of the insert.The patient's job as a laborer, and the associated heavy lifting may have contributed to the fracture, but no trauma was reported.Due to the missing fragments and secondary damages, a conclusion cannot be drawn regarding a possible cause for the fracture of the insert.This device is used for treatment, not diagnosis.Corrected data: e2: health professional.
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