Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: liner 2: 0001825034-2019-00273.
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Event Description
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It was reported that during initial hip surgery, the liner would not engage the cup.A second liner was attempted with the same results.The surgery was completed with a third liner.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Udi : (b)(4).Complaint sample was evaluated and the reported event was not confirmed.Device evaluation found multiple forms of damage.The barb is scraped such that a poly strand protrudes from the liner.The rim is scratched.A hole has been drilled through the liner during the removal from the shell.Both of the liners exhibit very minor surface scratching and scuffing to the outer diameter.Device history record (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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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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