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Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214)
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Patient Problems
Pain (1994); Local Reaction (2035); Reaction (2414)
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Event Date 08/02/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical product: 00801803602 ¿ cocr head ¿ 62611503, 00620205022 ¿ tm shell ¿ 61666771, 00630505036 - longevity liner ¿ 62621709.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.Multiple mdr reports were filed for this event, please see associated report: 0002648920-2020-00306.
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Event Description
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It was reported that patient underwent a left hip revision approximately 5 years post implantation due to elevated metal ion levels, altr, metallosis and in-vivo implant corrosion.During the surgery, the head and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
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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.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was confirmed by review of medical records noting patient was revised due to elevated metal ion levels, altr, metallosis and corrosion.It was noted that there was no severe bone or tissue destruction.The head and liner were replaced, the trunnion was cleaned and there was no intraoperative complications.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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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