It was reported that after acl reconstruction procedure, it was noted the endobutton rotated.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10 h3, h6: evaluation is not possible, as the unknown endobutton device will not be returned.The part and lot number have not been provided making an examination of the manufacturing records prohibitive.A review of the complaint records was also performed for this device family, which confirmed additional complaints have been reported within the scope of the reported study.The investigation was limited to the information provided.This investigation could not draw any conclusions about the reported event with the limited clinical details provided.If additional clinical details become available in the future, the investigation will be reopened.A review of the provided journal article reported that after acl reconstruction procedure, it was noted the endobutton rotated.The articles¿ clinical evaluation noted; the postoperative pivot shift test was negative in all cases, no loss of extension or loss of flexion of more than 5 degrees compared with the contralateral knee and there were no complications, such as painful irritation, associated with eb use.However, without the requested patient specific clinical information to assist with a clinical investigation a thorough medical investigation cannot be rendered.Should any additional medical information be provided this complaint would be re-assessed.
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