Model Number N/A |
Device Problems
Malposition of Device (2616); Migration (4003)
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Patient Problem
Failure of Implant (1924)
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Event Date 03/08/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source united kingdom.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.Citation: kendrick, b.(2023).Post-market clinical follow-up study to provide safety, performance and clinical benefits data of the arcos modular revision femoral porous coated stem (implants and instrumentation) ¿ a retrospective and prospective consecutive series study [review of post-market clinical follow-up study to provide safety, performance and clinical benefits data of the arcos modular revision femoral porous coated stem (implants and instrumentation) ¿ a retrospective and prospective consecutive series study].Mdrg2017-89ms-95h(revision 0.2).
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Event Description
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It was reported in a clinical study that two patients experienced subsidence of the stem where one patient also had retroversion and underwent a revision to a new stem component approximately 3.5 years post implantation.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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This follow-up report is being submitted to relay additional information.Component code: mechanical (g04)- stem no product was returned or pictures provided; 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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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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