Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Pain (1994)
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Event Date 07/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: partial femur cemented left medial, catalog #: 42558000101, lot #: 63813065 partial articular surface left medical, catalog #: 42518200308, lot #: 63882650.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Device remains implanted in patient.
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Event Description
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It was reported that patient underwent unicompartmental knee arthroplasty.Subsequently, the patient experience pain.At the diagnosis, sinking was seen on the tibial component two months post-primary arthroplasty.
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Manufacturer Narrative
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(b)(4).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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Event Description
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It was reported that patient underwent unicompartmental knee artrhoplasty.Subsequently, the patient experienced pain.At the diagnosis, subsidence was seen on the tibial component two months post-primary arthroplasty.It was further reported that patient a revision procedure.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed by review of radiographs received.Review of the x-rays confirms that the tibial component has subsided.The patient's bone quality was also found to be osteopenic.Device history record (dhr) was reviewed with no deviations identified.The report issue is considered confirmed, however, a definitive root cause cannot be determined.A summary of the investigation has been sent to the complainant.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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