Catalog Number 15-105004 |
Device Problem
Material Erosion (1214)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 05/18/2021 |
Event Type
Injury
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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 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.Concomitant medical products: item # 11-163668/ 32mm m2a mod head / lot # 036960.Item# 162253/ bi-metric porous fmrl/ lot# 709910.Item# 10-104058/ m2a-t m/h rad 2hl shl / lot # 135750.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -01692.
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Event Description
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It was reported that patient underwent left hip revision surgery 19 years post implantation due to elevated cobalt levels and pain.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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It was reported that patient underwent left hip revision surgery 19 years post implantation due to elevated cobalt levels and pain.No further event information available at the time of this report.
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Manufacturer Narrative
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Cmp-(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp)mmi review: impressions: ovoid-shaped well-marginated zone of lucency surrounding portions of the acetabular cup.This could be related to the event/deficiency description metal ions and metallosis.There is increased lateral inclination of the cup and this could be intentional based on surgical technique.Positioning does increase possibility of hip dislocation, which is not evident currently.If this is a new finding (based upon comparison to prior examinations), then positioning of the cup since prior time point could be related to loosening as a result of metallosis, but this is not confirmed based upon current imaging.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was 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 d10: item # 11-163668/ 32mm m2a mod head / lot # 036960 item# 162253/ bi-metric porous fmrl/ lot# 709910 item# 10-104058/ m2a-t m/h rad 2hl shl / lot # 135750 multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -01692.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined this component did not contribute to the reported event.The initial report was forwarded in error and should be voided.
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Event Description
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Upon reassessment of the reported event, it was determined this component did not contribute to the reported event.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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