Model Number N/A |
Device Problem
Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 110003451- g7 str modular shell inserter- 578800.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01585.Customer has indicated that the product will not be returned to zimmer biomet for investigation, remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.
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Event Description
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It was reported the threads wouldn't disengage from the cup and insert sticks when dropping down green/black handle.No further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the inserter is detached from the shell.No thread damage can be seen.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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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No additional information on the reported event.
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Search Alerts/Recalls
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