Model Number N/A |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign country: (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 that liner would not seat in shell during initial tha.Another device was used to complete surgery; no harm to patient.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D4: udi# (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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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Manufacturer Narrative
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Device was returned and evaluated against the complaint.Visual inspection found the barb to be scraped in 2 locations such that a strand of poly protrudes from the liner.No other evidence of damage was observed on the outer radius of the liner.The additional information does not change the outcome of the previous investigation.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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