Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Fall (1848); Joint Dislocation (2374)
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Event Date 05/26/2022 |
Event Type
Injury
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Event Description
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It was reported patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately 2 months and 2 weeks post implantation due to dislocation after a fall.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 110010265 7004640 g7 osseoti multihole 54mm f.110024464 471420 g7 dual mobility liner 44mm f.Unknown stem.Ep-200150 act artic e1 hip brg 28x44mm.Report source: foreign country: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device was not released by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 2022 01467.
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Manufacturer Narrative
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Per patient's surgeon, the cause of the fall was not device related as the components were well fixed upon revision.The cause of the dislocation was the fall and the dislocation was in a manner that the surgeon would normally expect from such an event.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Event Description
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Per patient's surgeon, the cause of the fall was not device related as the components were well fixed upon revision.The cause of the dislocation was the fall and the dislocation was in a manner that the surgeon would normally expect from such an event.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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