Catalog Number 110027734 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Failure of Implant (1924); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032)
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Event Date 03/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and 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 - 2022 - 00835, 0001825034 - 2022 - 00632.
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Event Description
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It was reported that the glenosphere disassociated from vrs baseplate.Despite successful patient follow up appointments at 3 and 6 months postoperatively showing good implant alignment, the patient was seen in the office with a disassociated glenosphere.The 36mm glenosphere and its taper adaptor had dislocated from the vrs baseplate.Upon revision surgery, new implants of the same dimensions were successfully placed.The central screw from the initial surgery was removed and not replaced at the revision.It was noted that the screw head may have been proud of fully seated within the vrs boss when checked with the vrs inserter prior to screw removal.The vrs inserter sat flush against the face of the vrs implant after the central screw was removed.Attempts have been made and no additional information is available at this time.
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Event Description
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No additional event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was also confirmed by review of radiographs and medical records.Review of the available medical records identified the following: (b)(6) 2022 appointment: increasing pain, poor forward elevation, x-ray ap & lateral right shoulder head disassociated from baseplate revision surgery planned.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D2 (device product code): phx.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 additional event information is available at the time of this report.
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Search Alerts/Recalls
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