Model Number N/A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2024 |
Event Type
malfunction
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Event Description
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It was reported that the screw cap was stripped and would not come out of shell.The surgeon decided to open a new cup.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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No further 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.One g7 pps ltd acet shell was returned and evaluated.Upon visual inspection the hex feature of the plug has been stripped and the plug could not be removed for further evaluation.A review of the device history records identified no related deviations or anomalies during manufacturing.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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