Results of investigation: it was reported that the patient had a shoulder prosthesis in 2014 (posttraumatic necrosis of the humeral head).Now the patient requires a revision because the rotator cuff had a rupture.The revision surgery did not take place yet.No information regarding the part numbers and the batch numbers of the parts, used in treatment, is available.Therefore, the complaint history as well as the batch records could not be reviewed.Additionally, no clinically relevant materials were received, therefore, a thorough medical assessment was not possible.As the devices are still implanted, a product evaluation could not be conducted.The risk is covered in the risk management files.The ifu lit.No.12.25 ed.07/10 does not list a rupture of the rotor cuff as a common side effect, however insufficient range of motion and shoulder instability are listed.Based on the available information, the failure mode cannot be confirmed and the root cause stays undetermined after investigation.Should additional information become available, this complaint will be reassessed.To date, no further actions are deemed necessary.Smith and nephew will monitor the implanted system for further similar issues.
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