TORNIER S.A.S. UNKNOWN ASCEND FLEX HUMERAL STEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Catalog Number UNK_WTM |
Device Problem
Malposition of Device (2616)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/16/2004 |
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 one patient that experienced malposition 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.Device not available.
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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 ascend flex hemi stemmed shoulder system.This report includes analysis of the clinical data that was collected on 394 patients, the cases in this study range from april 2004 and june 2021.This report was generated on june 3, 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 one patient experienced malposition which required revision surgery.
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Manufacturer Narrative
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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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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 ascend flex hemi stemmed shoulder system.This report includes analysis of the clinical data that was collected on 394 patients, the cases in this study range from april 2004 and june 2021.This report was generated on june 3, 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 one patient experienced malposition which required revision surgery.
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Search Alerts/Recalls
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