The manufacturer became aware of a literature published by the ¿hand center, isala klinieken zwolle, the netherlands¿.The title of this report is ¿trapeziometacarpal arthrodesis or trapeziectomy with ligament reconstruction in primary trapeziometacarpal osteoarthritis¿, published on may 07, 2014, and can be found at http://dx.Doi.Org/10.2106/jbjs.L.01344.The report is associated with the stryker ¿profyle hand system¿ and includes an analysis of the clinical data that was collected on 43 patients.The cases in this study range from 2008 to 2011.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that one patient experienced sensory disturbances.
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This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿hand center, isala klinieken zwolle, the netherlands¿.The article can be found at http://dx.Doi.Org/10.2106/jbjs.L.01344.The reported event could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author. more detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause. if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Device disposition unknown.
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