Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Joint Dislocation (2374); Unspecified Tissue Injury (4559)
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Event Date 08/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: catalog number: 00771100410 lot number: unknown brand name: m/l taper stem.Catalog number: 00620005222lot number: unknown brand name: trilogy cups.Unknown head.Unknown liner.Multiple reports were submitted along with this report: 0001822565-2021-02507, 0001822565-2021-02508, 0001822565-2021-02510.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 was revised due to dislocation approximately 5 years post implantation.During the revision, a lot of white fluid and tissue damage was noted.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Radiographs reviewed identified that the left hip arthroplasty components were anatomically aligned with no evidence of fracture or dislocation.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information 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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No further event information available at the time of this report.
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Search Alerts/Recalls
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