Catalog Number UNKNOWN GLENOID COMPONENT |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it 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 that 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 a patient underwent a right shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a patient matched glenoid product on an unknown day for an unknown reason.No contributing patient conditions or diseases were listed.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.The reported event is not confirmed.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 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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Event Description
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No further event information is available at the time of this report.
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Search Alerts/Recalls
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