Model Number N/A |
Device Problems
Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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Patient Problems
Joint Dislocation (2374); No Information (3190)
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Event Date 05/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant products: unknown, unknown humeral stem, unknown.Unknown, unknown glenoid, unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 11269, 0001825034 - 2017 - 11270.
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Event Description
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It was reported that the patient had an initial left shoulder arthroplasty on unknown date.Subsequently, the patient has been indicated for revision due to unknown reasons.No further information has been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.
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Event Description
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It was reported that the patient had an initial left shoulder arthroplasty.Subsequently, the patient has been indicated for revision due to dislocation.No further information has been provided.
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Manufacturer Narrative
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(b)(4).Investigation results remain unchanged as previously reported on 0001825034-2017-11268- 2 and root cause remains unknown.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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.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 the patient had an initial left shoulder arthroplasty.Subsequently, the patient was revised due to dislocation eight (8) months post initial surgery.No further information has been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Concomitant products: arcomxl retentive +3 mm humeral bearing part # xl-115365, lot # 418890.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.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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