Model Number N/A |
Device Problem
Failure to Osseointegrate (1863)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Type
Injury
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Event Description
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It was reported in a journal article that sixteen (16) patients underwent a revision of the acetabular component due to aseptic loosening.No information is available regarding the intervention or outcome of the patients.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Doi: https://doi.Org/10.1016/j.Arth.2022.01.053.
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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 information.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were 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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Search Alerts/Recalls
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