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 09/15/2023 |
Event Type
malfunction
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Event Description
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It was reported the elevated liner did not fit properly inside of the cup.The surgeon was able to reduce the hip in the final trial and the elevated liner came out easily.The surgeon tried a neutral liner.The neutral liner was also not fitting initially.The neutral liner was able to fit partially after three to four attempts.Attempts for additional information have been made and none has been provided.
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Manufacturer Narrative
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(b)(4).D10: 00875201036 36mm i.D.Size ii elevated rim liner use with 52mm o.D.Size ii shell 65918779.G2: foreign: india.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02736.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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No additional event information to report at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified there are circular indentations on the outside radius of the liner.There is also damage to the locking feature of the device.The neutral liner remains implanted.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined for the liners not seating properly.User error was identified as it was stated the surgery was completed with the liner only fitting partially.As per the trilogy it acetabular system surgical technique it is required to verify liner seating prior to completing the surgery.As per the longevity it highly crosslinked liner, improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions reducing the service life of the prosthetic implants.This complaint was confirmed based on the signs of use on the returned liner.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 additional event information to report at this time.
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Search Alerts/Recalls
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