The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.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.A review of the labeling did not indicate any abnormalities.As per ifu: contraindications: bone, musculature, tendons, or adjacent soft tissue compromised by disease, infection, or prior implantation, which cannot provide adequate support or fixation for the prosthesis.Known sensitivity to materials used in this device.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 when excessive demands are made upon it.Reuse of instruments designated as single use has been associated with necrosis of bone leading to implant failure.Also, as per ifu some of the adverse events are: there have been some reports of patients with metal sensitivity reactions following joint replacement.Implantation of materials such as cobalt chrome and/or titanium may result in foreign body reaction adjacent to the implant site.Injury to the surrounding nerves, blood vessels, tendons, or soft tissues can occur as a consequence of implanting this device.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device evaluated by mfr: device disposition unknown.
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The manufacturer became aware of a study from (b)(6) hospital (b)(6).The title of this study is ¿what we know after a decade of total wrist prostheses¿ and is associated with the remotion total wrist system.Within that publication, post-operative complications/ adverse events were reported, which occurred between 2009 and 2015.It was not possible to ascertain specific device catalogs from the report; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication.Therefore, 30 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses lysis.20 out of 22 cases.
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