Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The 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.
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Event Description
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It was reported that the surgeon attempted to impact the liner into cup and the ring popped off.There was no bone or other impinging material between ring and cup.A new liner was impacted in without difficulty.There was no known impact or consequences to the patient.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.One liner were returned and evaluated.Upon visual inspection the locking feature and the scallops have been damages.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot 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 information at the time of this report.
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Search Alerts/Recalls
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