Catalog Number 514.503 |
Device Problem
Improper Chemical Reaction (2952)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3008812173-2022-00003.Concomitant medical products: item#514.503; lot#209519521b05.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 a procedure the product would not mix.The case was aborted, and the patient did not receive treatment.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2.Upon reassessment of the reported event, it was determined to be not reportable.The reported event is for scp procedure, where 2 kits were both unable to mix as required and the procedure was postponed.As neither kit was able to be mixed as required, no injection was performed and the event was postponed, thus no adverse event or patient harm occurred.The initial report was forwarded in error and should be voided.
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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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