Catalog Number UNK_WTB |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Scar Tissue (2060)
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Event Date 03/11/2022 |
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 arthrofibrosis, which required revision surgery, 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 aequalis fx shoulder system.This report includes analysis of the clinical data that was collected on 476 patients, the cases in this study range from 16 april 2004 and 9 march 2022.This report was generated on march 11, 2022.During the review of the registry, it was not possible to establish specific device details, patient information, and no additional device information will be made available.It was reported that 1 patient experienced arthrofibrosis, 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 aequalis fx shoulder system.This report includes analysis of the clinical data that was collected on 476 patients, the cases in this study range from 16 april 2004 and 9 march 2022.This report was generated on march 11, 2022.During the review of the registry, it was not possible to establish specific device details, patient information, and no additional device information will be made available.It was reported that 1 patient experienced arthrofibrosis, which required revision surgery.
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Manufacturer Narrative
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Please note correction of the product details.
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Search Alerts/Recalls
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