Model Number 110031418 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 06/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: j7149801.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not 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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Event Description
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It was reported that the patient underwent an initial right shoulder arthroplasty.Subsequently, approximately four (4) months later the patient underwent a revision surgery due to the implants dislocating.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay corrected information.This follow-up report is being submitted as the notification date was incorrectly reported.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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