Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).D10: 110010246 item name g7 osseoti 4 hole shell 56mm f lot # 66175220; 110003453 item name g7 curved acet shell inserter lot # unknown.Multiple mdr reports were filed for this event, please see associated reports 0001825034-2024-00444; 0001825034 -2024 -00443.The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.
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Event Description
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It was reported that the acetabular inserter would not unscrew from the shell.Upon further attempts to release the shell from the inserter, the ball head hex driver broke off the tip of the device.There was no patient impact, surgical delay or foreign retained body.There is no additional information at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h6 h10 visual examination of the returned product identified the g7 ball hex driver fractured off and stuck in the threaded inserter shaft.Lot identification 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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Event Description
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There is no update to the prior event description provided.
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Search Alerts/Recalls
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