Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214); Naturally Worn (2988)
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Patient Problems
Failure of Implant (1924); Metal Related Pathology (4530)
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Event Date 11/12/2020 |
Event Type
Injury
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Event Description
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It was reported that patient underwent a left hip revision after an unknown amount of time post implantation due to metallosis.During the revision, corrosion was found on the taper of the femoral stem and was easily removed by the surgeon.A minimal amount of tissue with chronic synovitis was removed form the inferior aspect of the acetabulum.The femoral head was removed and replaced.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).Medical records were reviewed by an hcp and noted explant of the head, trunnionosis, metallosis, dark brown tissue, corrosion on taper, chronic synovitis, and black foreign body material.Visual examination of the provided pictures identified a taper adapter and mod head, the taper adapter has damage on the outside.Device history records were unable to be reviewed as the part and lot numbers were not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01519, 0001825034-2022-01520 and 0001825034-2022-01521.
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Event Description
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It was reported that patient underwent a left hip revision approximately 13 years post implantation due to metallosis.During the revision, corrosion was found on the taper of the femoral stem and was easily removed by the surgeon.A minimal amount of tissue with chronic synovitis was removed from the inferior aspect of the acetabulum.The femoral head was removed and replaced.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.D6a: unknown date in apr 2007 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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.Event is confirmed via medical records and provided photo.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 further information at the time of this report.
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Search Alerts/Recalls
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