Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported during an initial hip procedure the acetabular liner would not fit into acetabular shell properly.Liner was impacted into shell.The surgeon went to dislocate the hip to put the definitive head onto the stem and the acetabular liner came out of the shell.He tried to reseat the liner but it would not sit into the shell correctly.New liner was used.No additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.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 further event information available at the time of this report.
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Search Alerts/Recalls
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