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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant products: item #: unknown, unknown base plate, lot #: unknown; item #: unknown , unknown humeral stem, lot #: unknown; item #: unknown , unknown glenosphere, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.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 reports: 0001822565 - 2021 - 03652, 0001822565 - 2021 - 03653 , 0001822565 - 2021 - 03655.
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Event Description
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It was reported that patient underwent a left shoulder procedure.Subsequently, the patient is requesting material composition approximately 16 years later for devices due to unknown issues that could be a reaction to the implanted devices.The patient relayed that he has toxins in his body that are coming from the parts implanted and they are affecting his body.Patient has been feeling fatigued and unmotivated and pain in his body.He had a stroke and thinks it is from the toxins he has in his body.He has been doing his own research and has self-prescribed chelation therapy.Since he has started he is now able to exercise more.No revision has been reported to date.Attempts have been made and no further information has been provided.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, h2, h3, h6 reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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