Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Date 11/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item number 00801803601 item name femoral head sterile product do not resterilize 12/14 taper lot # 62829949.Item number 00630505036 item name liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells lot # 62827799.Unknown stem.The device will not be returned for analysis; due to the patient requested to have the explanted implants, however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00510.
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Event Description
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It was reported the patient underwent a left hip procedure.Subsequently, the patient was revised due to the cup loosening approximately 5 years later.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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The explanted devices were not returned for evaluation however an image was provided.The shell, screw, head and liner are pictured.The exterior of the shell shows some ingrowth debris.No further information can be identified from the provided image.Lot identification of the shell is necessary for review of device history records, lot identification was not provided.Medical records were not provided.A definitive root cause cannot 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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Search Alerts/Recalls
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