Device Problems
Device Dislodged or Dislocated (2923); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Joint Dislocation (2374); Insufficient Information (4580)
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Event Type
Injury
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Event Description
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It was reported patient has been indicated for revision due to unknown reasons.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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(b)(4).G2: foreign: japan.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional 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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It was reported patient has been indicated for revision due to glenoid component being dislodged.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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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.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The reported event is not confirmed.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 by the pmi group that a patient underwent a left shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a pmi product on an unknown day due to dislodged glenoid due to baseplate loosening.Attempts to obtain additional information have been made; however, no more is available.No additional patient consequences were reported.
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Search Alerts/Recalls
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