The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.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.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.
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The manufacturer became aware of a pmcf conducted by bellvitge university hospital in spain.The title of this report is ¿retrospective data collection of the treatment of humeral fractures with the t2 proximal humeral nailing system (phn)¿ which is associated with the stryker ¿t2 proximal humeral nailing (phn)¿ system.This report includes research done on 96 patients from the period january 2011 to july 2019.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses (2) cases of avascular necrosis for which nail was removed.The report states: [¿] patients presented avascular necrosis of the head of the humerus [¿].In two of them, the intramedullary nail was removed (one of these patients presented associated non-union and implant dislocation).It was not necessary to perform a shoulder arthroplasty in any of the cases, but the patients presented functional impotence without pain.
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