BIOMET UK LTD. OXF UNI PH3 SPH CUTTER MED; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
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Catalog Number 32-420330 |
Device Problem
Material Discolored (1170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2-foreign-germany 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 that after the sterilization process, the instrument became discoloured and is not suitable for reprocessing.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified: signs of wear on the cutting teeth and scuffs, scratches on the non cutting surfaces also there is discoloration on the surface of the cutter.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Reported event did not occur in an operating room or as part of a medical procedure; therefore, no medical records are available for review.With the available information, a definitive root cause could not 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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