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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Complaint history was unable to be performed, as the part number and lot number are 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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It was reported that the patient underwent initial right shoulder arthroplasty on an unknown date.Subsequently, the patient was revised due to unknown reasons.This is the second of three revisions for this patient.There was not much bone left on the glenoid side for fixation.Patient was aware of risk of failure & proceeded w/ the surgery.Patient was revised to a tm reverse shoulder at this time.Additional information was requested, but is unknown.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay corrected and additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017- 05214, 0001822565-2017-05215.
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Search Alerts/Recalls
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