WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN EVOLVE RADIAL HEAD; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
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Catalog Number UNK_WWA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 10/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number were not communicated.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.
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Event Description
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The manufacturer became aware of national registry released by the australian orthopaedic association national joint replacement registry.The report provides information on the usage and outcomes of the evolve proline elbow system.This report includes analysis of the clinical data that was collected on 737 patients, the cases in this study range from may 2005 and september 2021.This report was generated on 20 october 2021.During the review of the registry, it was not possible to establish a specific device details, patient information, and no additional device information will be made available.It was reported that 1 patient required revision surgery due to a bone fracture.This is patient 2 out of 2.
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Search Alerts/Recalls
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