The reported event could not be confirmed.The x-rays sent were reviewed by stryker¿s medical expert, and his clinical opinion about this case is the following: "unfortunately i have received only one image of an ap-view pain of the right hand of the patient.No date of the x-ray is provided.This circumstance affects the quality of the assessment.We see several severe degenerative changes in the bony substance of the wrist, the carpal bones, the metacarpalia as well as the phalanges.All of these changes may contribute to functional impairment and pain in the hand.The demotion wrist implant is also depicted.The radial part of the implant shows no sign of loosening.The carpal part of the implant, however, shows signs of loosening.The optech recommends to resect the lunate, the triquetrum, proximal scaphoid, head of the capitate, and head of the hamate and anchorage in the carpal bone, the scaphoid, the hamatum and the adjacent metacarpals.In the provided x-ray except of a rest of the trapezium and hamatum (both with degenerative structural change making the identification of the bones almost impossible) no further carpal bones can be identified.Additionally, we see a shortened, atrophic rest of the distal ulna.The base of the mc iii and iv show signs of loosening, but this can only be safely assessed with the missing x-ray of this control and the initial x-rays after the insertion of the implant.The x-ray shows destruction and degenerative luxation in several of the surrounding joints: mcp i, mcp ii+iii, pip ii, iii, iv.The loosening of the carpal part of the implant could contribute (or be the main root cause) of the pain (only at the wrist-the other mentioned changes will also cause severe pain in this case and it is questionable whether this can be distinguished by the patient)".Therefore, this event is classified as a mix of a user and environmental related issue.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
|