Additional manufacturer narrative reported event: an event regarding alleged dislocation involving a patient specific, proximal ulna replacement, ulna component.The event was confirmed by x ray review.Method and results: product evaluation and results: not performed as no items were received.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for distal humeral and proximal ulnar replacement which was inserted on (b)(6) 1993 (ulnar) and (b)(6) 2012 (humeral).The surgeon reported a dislocation of the elbow.The x-ray image provided shows that the elbow joint has disassociated between the humeral and ulnar components.Therefore, the radiographic review can confirm the clinical report and reason for revision.Product history review: a review of the product history records indicate the device was dispatched with no reported discrepancies.Complaint history review: there have been 2 other events.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes, and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.The reported device is similar to a device approved for compassionate use in the united states.
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