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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
Pain (1994); Burning Sensation (2146); Discomfort (2330); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02919, 0001825034-2023-02920, and 0001825034-2023-02921.D6a implant date: unknown date in october 2018 d10 medical devices: unknown vanguard femoral catalog#: ni lot#: ni; unknown vanguard tibial insert catalog#: ni lot#: ni; 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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It was reported that patient underwent a left knee procedure.Subsequently, patient reports swelling, a burning sensation, tightness, discomfort, and pain.Patient returned to the surgeon for a shot to address the pain.No revision procedure has been reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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 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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