Model Number DWP4396 |
Device Problems
Component Missing (2306); Device Dislodged or Dislocated (2923)
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Patient Problems
Joint Dislocation (2374); Insufficient Information (4580)
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Event Date 02/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device retained by hospital.
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Event Description
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The patient had to come back in less than a week after their initial surgery to have a revision surgery to have the disassociated reversed insert explanted and a new one implanted.Upon getting into the revision surgery, the poly had indeed disassociated from the humeral stem and there appeared to be no locking ring inside of the poly.
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Manufacturer Narrative
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The reported event was not confirmed.The device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned for investigation and no other evidence was provided.A review of the labeling and the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
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Event Description
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The patient had to come back in less than a week after their initial surgery to have a revision surgery to have the disassociated reversed insert explanted and a new one implanted.Upon getting into the revision surgery, the poly had indeed disassociated from the humeral stem and there appeared to be no locking ring inside of the poly.
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Search Alerts/Recalls
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