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Catalog Number UNK BASEPLATE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Erosion (1750)
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Event Type
Injury
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Event Description
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It was reported by the pmi group that a patient previously underwent a revision surgery on an unknown date due to rotator cuff failure.Subsequently, the patient was later being considered for a pmi device due to bone loss and the surgeon wanting to avoid taking excess bone, but due to health issues the patient's pmi case was cancelled.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot 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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