Catalog Number 00588005014 |
Device Problems
Device Dislodged or Dislocated (2923); Migration (4003)
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Patient Problem
Joint Dislocation (2374)
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Event Date 09/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown femoral component: catalog#ni, lot#ni.Report source: foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 patient underwent a revision knee arthroplasty.Six years post implantation the articular surface dislocated, requiring a second revision surgery.The poly was exchanged without incident.Attempts have been made and no further information has been provided.
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Event Description
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It was reported that patient underwent a revision knee arthroplasty.Six years post implantation the articular surface dislocated, requiring a second revision surgery.The pin had become unscrewed in the knee.Surgeon screwed in a new pin and exchanged the poly without incident.All other components remain implanted.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D10: medical product: fem size e, right: catalog#00588001502, lot#62867390.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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No further event information at 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.Visual examination of the returned product identified signs of extreme wear (nicked, gouged, micro motion), the thread on the hinge post extension has fractured.Device was submitted for further analysis.Analysis determined the hinge post thread fractured due to shear overload.Excessive smearing observed near the suspected crack initiation edge on the hinge post thread fracture surface.Device history record was reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is disassociation of the right knee arthroplasty with the hinge screw displaced and interposed between the femoral and tibial components.The polyethylene implant appears to be anteriorly displaced.No fracture is identified.Implant fit and alignment is maintained.No implant loosening, abnormal radiolucency or other abnormality.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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