WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN EVOLVE RADIAL HEAD; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
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Catalog Number UNK_WWA |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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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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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 1 patient that experienced incorrect sizing which required revision surgery 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 (b)(6) 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 (b)(6) 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 experienced incorrect sizing which required revision surgery.
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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 (b)(6) 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 experienced incorrect sizing which required revision surgery.
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Manufacturer Narrative
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Correction: h1: this is not a summary report.The number of events summarized field is blank as this mdr submission pertains to one patient.
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Search Alerts/Recalls
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