Internal complaint reference: case-(b)(4).Ingemar sernbo, olof johnell, carl-frederik gentz, jan-aake nilsson.(1998).Unstable intertrochanteric fractures of the hip: treatment with ender pins compared with a compression hip-screw.The journal of bone and joint surgery.
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Section h10: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the article noted three (3) patients required removal of the implants due to postoperative pain; however, the timeframe during which these interventions were performed and the specific explanted components are not known.Reportedly, there is no contact information available for this literature case; therefore, patient specific supporting documentation or current patient status has not been provided as of the date of this medical investigation.The images provided in the article have been interpreted within the text; therefore, no further analysis of the imaging is required.The clinical root cause of the reported events cannot not be further assessed.The patient¿s outcome beyond that which was documented in the article cannot not be determined as the patient¿s current health status remains unknown.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors that could contribute include but are not limited to traumatic injury and/or joint tightness.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Internal complaint reference number: (b)(4) section h6 (clinical code) was corrected.
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