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Model Number N/A |
Device Problems
Material Erosion (1214); Migration or Expulsion of Device (1395)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994)
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Event Date 08/25/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant products: 118001, versa-dial/comp ti std taper, 297720.115330, biomod/comp rev base std, 436740.115310, comp rvrs shldr glnsp std 36mm, 593670.11-113706, bio-mod st.10x115 w/align hole, 936090.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 07589.0001825034 - 2017 - 07590.0001825034 - 2017 - 07591.
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Event Description
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It was reported a patient underwent shoulder revision approximately six years post-implantation due to pain, dysfunction, aseptic loosening, elevated metal ion levels, and adverse local tissue reaction.During the revision, the glenosphere and baseplate were found to be loose.Extensive wear on trunnion was noted, which is suspected to be the source of the metallosis and metal ion elevation.All components were revised.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined that this device was not involved in the event.The initial report was submitted in error and should be voided.
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Search Alerts/Recalls
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