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Catalog Number 61.27.28-46 |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Medical devices: bipolar shell, modular, 46; item# 61.27.00-46; lot# unknown.Foreign: austria.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 - 00097.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported an intra operative complication occurred where by an inlay did not seat properly in the shell.The surgeon tried a second inlay but that also did not seat properly, and could not be removed from the shell.The surgeon removed both the shell and second inlay.Surgery was completed with a new shell and inlay.No known impact or consequence to the patient.Due diligence is in progress for this complaint; to date what additional information that was received has been mentioned in this report, no product has been received yet.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d2, d4, d9, g3, g6, h2, h3, h4, h10.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10 ¿ associated products: izb 12/14 cocr hd 28mm x 0; item# 802202802; lot# 3089309.The modular bipolar shell, the modular bipolar liner and the head were returned for investigation.Visual examination identified that the items were returned assembled together.As it is possible to see from the side view of the assembled products, the liner is not sitting correctly in the shell, but it is tilted.The outer surface of the shell shows some scratches.The inner surface of the shell as well as the six flutes along the circumference shows some scratches.The outer surface of the liner shows some scratches and dents.Moreover, the six knobs along the circumference are damaged and deformed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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