WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN EVOLVE RADIAL STEM; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
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Catalog Number UNK_WWA |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/20/2021 |
Event Type
Injury
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Event Description
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The manufacturer became aware of national registry released by the (b)(6) 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 5 patients experienced revision surgeries for unknown reasons.
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Manufacturer Narrative
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This record is a consolidation of events summarized as part of literature review, when device and patient information is not available.This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged 5 patients that experienced revision surgeries for unknown reasons as mentioned in the registry could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
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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 had revision surgery for unknown reasons.This is patient 1 out of 5.
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Manufacturer Narrative
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Correction: b5: executive summary.H1: this is not a summary report.The number of events summarized field is blank as this mdr submission pertains to one patient.H6: device code was revised to insufficient information as the reason for the revision surgery is unknown and therefore accurate code cannot be establish.The reported event could not be confirmed, since the device was not returned for evaluation and no additional information was 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.
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Search Alerts/Recalls
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