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Model Number N/A |
Device Problem
Corroded (1131)
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Event Date 11/29/2023 |
Event Type
Injury
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Event Description
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It was reported the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 10 years later due to elevated ion levels.An mri showed a collection of fluid and debris.The trunnion of the stem showed signs of corrosion and discoloration.It was reported that no further information is available.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2023-00315.D10: cat# 00630505636, lot# 62387796, liner standard 3.5 mm offset 36 mm i.D.For use with 56 mm o.D.Shell.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 information 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.Proposed component code: mechanical (g04) stem.The stem was not returned and remains implanted.Pictures provided show dark discoloration and bio-debris to the trunnion.No further evaluation can be made from the provided pictures.Part and lot identification are necessary for review of device history records, neither were provided for the stem.Medical records were not provided.Image assessed but not sent to mmi.Trunnion corrosion is not visible on xray and explant/intraop images within the subforms provide sufficient evidence of findings.Sending the image would not enhance the investigation.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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