Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Swelling/ Edema (4577)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent diagnostic intervention (biopsy for metal allergy) greater than six months from initial surgery.The patient also experiences pain and swelling.Due diligence is in progress for this event; to date no further information has been provided.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item name: oxf twin-peg cmntd fem md pma ; item#: 161469; lot#: unknown; item name: oxf uni tib tray sz d lm pma, item#: 154724; lot#: unknown; item name: refobacin bc r 1x40 us; item#: 110034355; lot#: unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001822565 - 2023 - 00004.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay corrected information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00004, 3002806535 - 2023 - 00005.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted. .
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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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.Devices are used for treatment.Medical records 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.
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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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Search Alerts/Recalls
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