Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); Joint Dislocation (2374)
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Event Date 07/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Unknown if the liner was replaced in first revision.Concomitant medical products: 010001033 ¿ cocr head ¿ 6411879.11-301416 ¿ arcos distal stem ¿ 348660.11-301113 ¿ arcos cone ¿ 301113.Unknown cup ¿ unknown part and lot.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product was not returned by the patient.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 - 2020 - 03179.
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Event Description
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It was reported that patient underwent a second right hip revision approximately 3 months post first revision due to pain and dislocation.The head, liner and stem were removed and replaced.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.The following sections were updated/corrected updated: d6; g4; h2; h3; h6.Reportable event was unable to be confirmed due to limited information provided by the customer.X-rays reviewed by a third party hcp notes right total hip arthroplasty with placement of a lateral femoral plate and cerclage wire fixation device for what appears to be fractures involving the greater and lesser trochanter.There are due to the previous fracture and not related to this event.The dhr was reviewed and no discrepancies were found.The root cause is 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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Search Alerts/Recalls
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