D4 changed to unknown; originally provided lot# is invalid the reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿strenuous loading, excessive mobility, and articular instability all may lead to accelerated wear and eventual failure by loosening, fracture, or dislocation of the device.Patients should be made aware of the increased potential for device failure if excessive demands are made upon it.Adverse effects may necessitate reoperation, revision, or fusion of the involved joint.While the expected life of joint replacement components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential restoration of mobility or reduction of pain.However, due to the many biological, mechanical and physiochemical factors which affect these devices, the components cannot be expected to withstand the activity level and loads of normal healthy bone for an unlimited period of time.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
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