Model Number N/A |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Hip Fracture (2349)
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Event Date 04/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.(b)(4).There are warnings in the package insert that state that this type of event can occur: under instructions for use, "select head mold and stem mold sizes appropriate for producing the temporary hemi-hip prosthesis to fill the space vacated by the explanted prostheses and any other explanted material." remains implanted.
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Event Description
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During a procedure to exchange cement spacer molds, the patient's femur fractured as the hip stem spacer mold was being impacted.The spacer mold was reported to be too large anterior-posterior.Cables were implanted to fix the fracture.There was a one hour delay in procedure.
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Manufacturer Narrative
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This follow-up report is being submitted to relay corrected and additional information.Reported event was confirmed by review of operative notes.No devices were received, however, photographs of the explants show soft tissue on the stem spacer molds.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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During a procedure to exchange cement spacer molds, the patient's femur fractured as the hip stem spacer mold was being impacted.The spacer mold was reported to be too large anterior-posterior.Cables were implanted to fix the fracture.There was a one hour delay in procedure.Patient underwent planned re-implantation of left hip prostheses approximately 6 weeks afterward, during which it was noted that the femur showed osseous healing and reasonable integrity.
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Manufacturer Narrative
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This supplemental report is being filed to relay additional information.
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Search Alerts/Recalls
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