Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.This report is number 4 of 4 mdrs filed for the same patient (reference 1825034-2016-04993 - 04996).
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Event Description
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Legal counsel for the patient is reporting that the patient has indicated the need for a possible revision due to complication with a revised shoulder approximately 6 years post-implantation.No revision has been reported to date.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.
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Manufacturer Narrative
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This follow-up report is being filed to correct information.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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Legal counsel for the patient is reporting that the patient has indicated the need for a possible revision due to their shoulder being "broke" and unspecified complications with a reverse shoulder arthroplasty approximately 4 years post-implantation.No revision has been reported to date.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.
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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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Search Alerts/Recalls
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