Model Number N/A |
Device Problems
Fitting Problem (2183); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Information (3190)
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Event Date 01/16/2017 |
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.
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Event Description
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During the procedure, the acetabular liner could not be seated within the cup.After several attempts, another cup and liner were used to complete the procedure.
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Manufacturer Narrative
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Concomitant products: 00875200832 liner elevated rim 32 mm i.D.Size gg for use with 48 mm o.D.Size gg shell 63303262.Complaint sample was evaluated and the reported event was not confirmed.As returned, the device shows minor scuffs and scratches.The damage likely occurred during shell insertion.Dimensional measurements of the shell as measured were conforming to the device print specifications.Device was likely conforming when it left zimmer biomet control as there was no evidence that states otherwise.The correct number of screw holes was verified per print.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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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It was reported that during the procedure, the acetabular liner could not be seated within the cup.After several attempts, another cup and liner were used to complete the procedure.A 70 minute delay occurred during the procedure.Attempts to obtain additional information have been made; however, no more is available.
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Search Alerts/Recalls
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