Model Number N/A |
Device Problem
Component or Accessory Incompatibility (2897)
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Patient Problem
Hip Fracture (2349)
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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 the lot released with no recorded anomaly or deviation.This report is number 1 of 2 mdr's filed for the same event (reference 0001825034-2016-02870 / 02871).Product requested, not yet received.
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Event Description
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During a total hip arthoplasty the liner would not seat in the shell after several attempts at impaction.Another liner was tried with the same result.The surgeon then noticed that the patient's pelvis had fractured and removed all implants to postpone the procedure until the fracture heals.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Concomitant medical product - biomet cup catalog#: 110010243 lot#: 3754245; biomet cup catalog#: 110010263 lot#: 3767351; biomet femoral stem.The liner and shell dimensions showed acceptable to print specification.On the assembled components, the oriented/alignment of the scallops visually/manually review showed within design intended.Therefore, products likely left zimmer biomet control conforming, and a root cause cannot be determined.
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Manufacturer Narrative
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This follow-up report is being filed to correct information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay corrected and additional information.
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Search Alerts/Recalls
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