This complaint was identified during review of a journal article, so information about the case is limited.It is important to note there was an attempt to request additional information which was unsuccessful.Due to this complaint being identified during review of a journal article there was no product returned; therefore, no physical evaluation could be conducted.The device history records could not be reviewed due to lack of product identification and no lot number provided.Zimmer periarticular locking plates are used for treatment.A patient history review indicated that after the plate broke the patient underwent an additional procedure of re-fixation and also has a history of lung cancer.There was no particular product part or lot numbers provided, so a complaint review could not be performed.Product was used to treat femur fracture in patient and failed (fracture) approximately 8 months post op which is consistent with fatigue failure; however, with the limited information, the exact cause of the complaint cannot be determined.
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