Model Number N/A |
Device Problem
Corroded (1131)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 12/21/2023 |
Event Type
Injury
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Event Description
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It was reported that approximately six years post implantation, the patient experienced a pseudotumor due to trunnionosis, which was aspirated.A revision is pending but has not been scheduled to date.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00069.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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: d4; g3; h2; h3; h4; h6.H6: proposed component code: mechanical (g04)- head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed on (b)(6) 2017.Follow up appointments after the revision indicated the patient had no pain and was satisfied with the hip.An mri report from (b)(6) 2023 indicated there was a pseudotumor likely associated with trunnionosis.An aspiration was performed to reduce the symptoms, with a revision surgery pending.A definitive root cause cannot be determined.This complaint was confirmed based on the provided medical records.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 is available at the time of this report.
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Search Alerts/Recalls
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