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 08/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 42542007502 - psn rev tib fixed keel cmt sz f r - 64835313.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 during an initial surgery, the surgeon was trying to insert the poly, however, the implant would not engage posteriorly with the tibial component.Due to this, the instrument was unable to snap the poly in completely.The surgical technique was utilized.There was no surgical delay.The surgery was completed with another device.No known impact or consequence 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.Visual examination of the returned articular surface identified damage to the distal surface (nicked/gouged) and the dovetail was found to be compressed and flared out.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for inserting the articular surface are provided in the surgical technique.The root cause is attributed to use error.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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