The associated complaint devices were not returned.The clinical/medical team concluded, unable to rule out the malpositioned prosthesis, leg-length discrepancy, ¿infection treatments¿, and continued motion along with the patient¿s comorbidities as likely contributing factors to the reported non-union of the trochanteric region/gt.However, without the supporting operative reports, lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause cannot be determined and a causal relationship with the cables cannot be confirmed.The patient impact beyond the reported non-union, left hip revision left trochanteric/gt orif and expected post-op convalescence cannot be determined.No further medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.
|